Podcasts about clinical investigation

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.  Who is Carmen Bellebna?  Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ 

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode.  Who is Cecile van der Heijden?  Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/  Axon Lawyers website: https://www.axonlawyers.com/  EHDS: https://www.european-health-data-space.com/  Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/  

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we'll let you know when and why you should involve them earlier. Listen to this episode.  Who is Aouda Ouzzaa?  Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD).  Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations.  As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges.  Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success.    Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32  SmartQARA website: https://smartqara.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/  

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable.  Who is Adam Isaacs Rae?  Chartered quality professional with a Master's Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Adam Isaacs Rae LinkedIn:   https://www.linkedin.com/in/adam-isaacs-rae/ https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you.  Who is Yassine Bader?  Coach expert en transition de carrière et leadership, Yassine Bader cumule plus de 15 ans d'expérience au cœur de l'industrie (automobile, chimique, dispositifs médicaux, transport, pharmaceutique et agroalimentaire), accompagnant avec succès plus de 100 cadres vers une indépendance entrepreneuriale inspirante et un leadership d'excellence. Son approche : pragmatique, percutante, tournée vers l'action et les résultats concrets. Créateur du guide gratuit et fondateur du programme ManagerImpact, il équipe les managers d'outils précis et immédiatement exploitables pour devenir des leaders alignés, confiants et reconnus. Très prochainement, il dévoilera un séminaire exclusif destiné aux cadres industriels décidés à franchir le pas vers le consulting et le management de transition freelance, en leur fournissant toutes les clés indispensables pour réussir avec confiance leur nouvelle vie professionnelle. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Yassine Bader LinkedIn: https://www.linkedin.com/in/yassine-bader-yab/ Programme Yassinebader: https://programme.yassinebader.com/manager-impact Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA.  Who is Cyrille Michaud?  Co-founder and managing partner of MD101 Consulting. Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices. Specialties: Software Processes Management. CE Mark & FDA 510k 21 CFR 820 - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - IEC 60601 - IEC 82304-1 - UL 2900-1 - IEC 81001-5-1 Agile Methods applied to medical device software design. Cybersecurity applied to medical devices. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Cyrille Michaud LinkedIn:  https://www.linkedin.com/in/cyrillemichaud/  MD101 : www.MD101.io  Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings  Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released  FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English)  Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister  Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Send us a textDr. Jessica Sacher, Ph.D. is Co-Founder of Phage Directory ( https://phage.directory/ ), a global network of phage researchers from more than 80 countries, where she directs its phage-sourcing and community-building efforts, including coordinating over 50 phage-finding efforts, where a network of more than 1,300 members of the global phage community volunteer their time and lab space to identify active phages for patients.Dr. Sacher is also a Staff Scientist at Stanford University School of Medicine ( https://profiles.stanford.edu/jessica-sacher ) in Dr. Paul Bollyky's lab where she leads strategy & lays groundwork for a new phage-based therapeutic development and delivery center at Stanford, developing manufacturing processes and quality control pipelines for clinical-grade phage biologics, as well as evaluating phages as gene and peptide delivery vectors for eukaryotic and microbial cells.Dr. Sacher was previously a member of Prof. Jon Iredell's group in Sydney, Australia as a postdoctoral research scientist for the Phage Australia project where she developed and streamlined Phage Australia's phage selection, biobanking, and manufacturing process, to make phage therapy available for patients Australia-wide and eventually beyond.Dr. Sacher received her PhD in Microbiology and Biotechnology in 2018 from the University of Alberta, Canada.Dr. Sacher is also Founder, Editor, Writer of Capsid & Tail: the phage community newsletter, a weekly report on bacteriophage news and researchImportant Episode Links -  Bacteriophage therapy for multidrug-resistant infections: current technologies and therapeutic approaches - Published March 3, 2025  - The Journal of Clinical Investigation -https://www.jci.org/articles/view/187996The Citizen Phage Library (https://citizenphage.com) #JessicaSacher #PhageDirectory #Bacteriophage #StanfordUniversity #Campylobacter #SteffanieStrathdee #Microbiology #PhageBiobank #Biofilms #AMR #AntimicrobialResistance #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #ViralPodcast #STEM #Innovation #Technology #Science #ResearchSupport the show

https://www.pinterest.com/easymedicaldevice In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics So stay tuned.  Who is Tibor Zechmeister?  Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of Regulatory and Quality Flinn.ai | Notified Body Auditor | MedTech Entrepreneur | Software Solutions for Regulatory Automation with AI Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Tibor Zechmeister LinkedIn:  https://www.linkedin.com/in/tibor-zechmeister/  Flinn.ai Website: https://www.flinn.ai/  ISO 13485:2016 https://www.iso.org/standard/59752.html  ISO/TR 80002-2:2017: https://www.iso.org/standard/60044.html  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned.  Who is Darrin Carlson?  Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers.   Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Darrin Carlson LinkedIn:  https://www.linkedin.com/in/darrinlcarlson/  Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix  FDA page on Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters  FDA page on 483 data: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Sponsor Medboard: https://www.medboard.com/   Europe Health Data Legislation - Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030 FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf eIFU proposal until March 21st- eIFU for professional user:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en 14th Notified Body Under IVDR - Centro Nacional de Certification de Productos Sanitarios: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43640&filter=notificationStatusId:1 Exceptional access of Non-CE Medical Devices - France simplified form: https://ansm.sante.fr/actualites/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm EMA scientific Advice for High-risk device - Portal available: https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices Guide: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf IGJ on Generative AI in Healthcare - Be careful: https://www.igj.nl/zorgsectoren/medische-technologie/publicaties/publicaties/2025/02/10/igj-roept-zorgaanbieders-op-ga-zorgvuldig-om-met-invoering-van-generatieve-ai-toepassingen Pilot for Clinical Investigation and Performance Study - 1 application for all member states: https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en FAQ: https://health.ec.europa.eu/document/download/7ee00635-08dd-4c24-b892-74fc8eebfb54_en?filename=md_ci_pilot-ci-ps_faq_0.pdf Participating member states: https://health.ec.europa.eu/document/download/e987dcf9-cc8c-44c4-b772-18919cd3f84c_en?filename=md_ci_pilot-ci-ps_ms-pilot-coordinated-assessment.pdf What is an AI system - Read the guide: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application   Switzerland Swissmedic assessment on PMS - Result is BAD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.html   UK IVD registration in the UK - Transition to IVDR: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market EU IVDD Extension:  https://www.gov.uk/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices Reliance on Exention of CE- Reusable Class I devices : https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif#reliance-on-extended-certificates-in-great-britain-gb-   Webinar 28 March - AI in Healthcare - EU priorities and Ecosystem Synergies: https://digital-strategy.ec.europa.eu/en/events/ai-healthcare-eu-priorities-and-ecosystem-synergies   Newsletter Easy Medical Device Newsletter - Get fresh information: https://www.linkedin.com/posts/easymedicaldevice_medicaldevices-mdr-regulatorycompliance-activity-7304455925044531200-mKt0?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI Medtech Leading Voice Newsletter -  Reference a lot of Medical Device posts: https://www.linkedin.com/newsletters/medtech-leading-voice-6871913764770324480/   ROW Australia: Ask consent if product not compliant - Not compliant to the Essential Principles: https://www.tga.gov.au/resources/resource/reference-material/consent-medical-devices-do-not-meet-essential-principles South Africa: Classification rules - Some rules were updated: https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf Application to Canada - Draft guidance: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/draft-guidance-on-managing-applications-for-medical-device-licences-eng.pdf   Podcast   Episode 323 - The good, the bad and the ugly of certification bodies with Mark Rogovoi; https://podcast.easymedicaldevice.com/323-2/ Episode 324 - How and who to build your Risk Management File with Bijan Elahi: https://podcast.easymedicaldevice.com/324-2/ Episode 325 - FDA: Advantage of the Breakthrough Device Program with Michelle Lott: https://podcast.easymedicaldevice.com/325-2/ Episode 326 - How to avoid Clinical Investigation for your Device with Hatem Rabeh: https://podcast.easymedicaldevice.com/326-2/

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let's clarify all this and give you the right strategies for your Medical Devices. So stay tuned.  Who is Hatem Rabeh?  Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.   With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems.  His expertise covers literature reviews, clinical strategy, and regulatory compliance.   Hatem also shares his knowledge through online training, consulting, and LinkedIn content.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project. On some of my consulting projects, I ask people if they can send me their Risk Management File, which usually follows by “I don't have one” and then by “How can we create one?”. So Today Bijan Elahi who is an expert on risk management will explain the best way to start such project.  Who is Bijan Elahi?  Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and an affiliate professor at Drexel University. Previously he served as the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).  Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling medical book: Safety Risk Management for Medical Devices, published by Elsevier publishing.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Linkedin Page: https://www.linkedin.com/in/bijanelahi/  Medtech Safety website: https://www.medtechsafety.com/ Safety Risk Management for Medical Devices Book: https://www.amazon.com/Safety-Risk-Management-Medical-Devices-ebook/dp/B09M3QXNL9/ref  Conference website: https://medsafetyconf.net/home.php  Conference registration page (early bird discounts end on 28 February): https://medsafetyconf.net/registreren.php  Bijan's email: bijan@medtechsafety.com   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Send us a textWelcome to the third episode of season five, in conversation with Professor Cynthia Gyamfi-Bannerman. Professor Gyamfi-Bannerman's BioDr. Gyamfi-Bannerman is Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at UC San Diego Health, joining the faculty at UCSD in 2021. She holds the Samuel SC Yen Endowed Chair at UCSD and is a Professor with Tenure. She is board certified in both Obstetrics & Gynecology and Maternal-Fetal Medicine and focuses her career on obstetric complications with a primary focus on preterm birth prevention. Dr. Gyamfi is a proficient, NIH funded researcher whose research has focused on preterm birth prediction and prevention and in interventions to improve outcomes for those delivering preterm, namely antenatal corticosteroids. Results of her randomized clinical trial on antenatal corticosteroids in women at risk for late preterm birth were published in the New England Journal of Medicine and changed obstetric practice in the United States. She also conducts research in the areas of preeclampsia, infectious disease, maternal morbidity and health disparities with over 200 peer-reviewed publications.She is currently the Steering Committee Chair of a multi-center NIHLBI ENRICH study focused on improving maternal and childhood outcomes for pregnant individuals from poorly resources backgrounds, and Steering Committee Chair for the Preventing pre- eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening (PEARLS study), assessing aspirin dosing in sub-Saharan Africa. Recently, she was elected to the American Society for Clinical Investigation, a national medical honor society. Finally, she serves on the NICHD Council.Aside from her clinical and research endeavors, Dr. Gyamfi is the Immediate Past President for the Society for Maternal-Fetal Medicine (SMFM), the national and international society representing all perinatologists after completing her President in February, 2025. She is actively involved in writing clinical guidelinesin obstetrics for both SMFM and the American College of Obstetricians and Gynecologists and continues to mentor trainees and junior faculty from around the world.https://providers.ucsd.edu/details/1568494250/obstetrics-gynecologyPodcast information:We have not included any patient identifiable information, and this podcast is intended for professional education rather than patient information (although welcome anyone interested in the field to listen). Please get in touch with feedback or suggestions for future guests or topics: conversationsinfetalmed@gmail.com, or via Twitter (X), Bluesky or Instagram via @fetalmedcast.Music by Crowander ('Acoustic romance') used under creative commons licence. Podcast created, hosted and edited by Dr Jane Currie. 

In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you'll see that this is not all good.  Who is Mark Rogovoi?  Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master's degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Send us a textIn this episode of the Gut Feelings podcast, Ashley and Danielle talk with Dr. Bincy Abraham, an expert in inflammatory bowel disease (IBD). Dr Abraham shares her experience and insight into the complexities of managing IBD. Bincy P. Abraham is the Distinguished Professor and Director of the Fondren Inflammatory Bowel Disease Program at the Underwood Digestive Diseases Center of Houston Methodist Hospital. She is also the Program Director for the Gastroenterology Fellowship at Houston Methodist Hospital. She earned her medical degree from University of Texas Medical Branch, Galveston, TX, where she continued with residency training in internal medicine and fellowship in gastroenterology. During fellowship, she received specialized training in inflammatory bowel disease and earned her degree in Masters of Clinical Investigation. She also completed a National Visiting Fellow Inflammatory Bowel Disease Rotation program through the Crohn's and Colitis Foundation in Cedars Sinai Hospital in Los Angeles. She has chaired the Southern Regional chapter of the CCFA Medical Advisory Committee, served as president of the Texas Gulf Coast Gastroenterology Society, is involved in national committees for and is a Fellow of the American College of Gastroenterology, American Gastroenterology Association, American Society of Gastrointestinal Endoscopy, and Crohn's and Colitis Foundation. She is trained in and passionate about intestinal ultrasound in IBD patient care. Dr. Abraham discusses the importance of nutrition and emphasizes the need for patient empowerment. She also addresses common patient concerns regarding treatments and nutritional deficiencies. A big takeaway for us is: We don't have to suffer as IBD patients. There are options now that weren't available even 10 years ago that can significantly improve patient's quality of life and decrease the risk of complications with IBD. We discuss:how nutrition plays a crucial role in managing IBDhow dietary restrictions can be challenging and can lead to nutritional deficienciessome treatment options available now, including combining therapies that can improve outcomeshow active inflammation poses significant health riskspatient empowerment is essential in IBD managementwhat Dr Abraham tells patients that may be hesitant to try IBD medicationregular nutritional assessments are vital for IBD patientsmental health is an important aspect of IBD careWant to work with The Crohn's and Colitis Dietitians but have questions?Book a call - HEREMusic from #Uppbeat (free for Creators!):https://uppbeat.io/t/the-lakes/bluebirdLicense code: FTTITUEPIFFollow us on instagram @crohns_and_colitis_dietitiansFollow us on youtube @thecrohnscolitisdietitiansWe love helping provide quality content on IBD nutrition and making it more accessible to all through our podcast, instagram and youtube channel. Creating the resources we provide comes at a significant cost to us. We dream of a day where we can provide even more free education, guidance and support to those with IBD like us. We need your support to do this. You can help us by liking episodes, sharing them on your social media, subscribing to you tube and telling others about us (your doctors, friends, family, forums/reddit etc). Can you do this for us? In return, I promise to continually level up what we do here.

In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you.  Who is Adam Isaacs Rae?  Chartered quality professional with a Master's Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Adam Isaacs Rae LinkedIn:  https://www.linkedin.com/in/adam-isaacs-rae/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Joan D'Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow.  Who is Joan D'Souza?  I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion for learning, and a longstanding insight into the pharmaceutical sector. I am driven, hard-working, enthusiastic, and always willing to take on new responsibilities. Therapeutic areas: vaccines, endocrinology, immunology, rare diseases, gastroenterology, autoimmune diseases, cardiovascular diseases, dermatology, medical devices, drug-device combinations, oncology, and neurology. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Joana de Souza LinkedIn:  https://www.linkedin.com/in/drjoanswatidsouza/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where  pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.  Who is Khanyisile Nkuku?  Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration  Officer  at the South Africa Competent Authority (SAHPRA) ,  she contributes her expertise in the assessment and registration of medical devices & IVD's in South Africa  to promote medical device & IVD access on a global scale, with a particular focus on African countries. She holds a Bachelor of Pharmacy  honours degree ,a Master's in Pharmacy administration & Policy Regulation ,  and is currently busy with Masters in Business Administration in Healthcare Leadership . She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance. She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF)  technical mainly the MDA-TC ( Medical device Assessment Technical committee  member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees . Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9 SAHPRA Website: https://www.sahpra.org.za/medical-devices/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

We're thrilled to share a special episode drop from one of our producers, Kira Dineen, and her flagship podcast, DNA Today! As a multi award winning genetics podcast with over 12 years of groundbreaking episodes, DNA Today explores the latest in genetics and genomics through expert interviews and engaging discussions.    To celebrate the new year, this episode reflects back on the top genetics and genomics news stories during 2024. The top stories we chatted about are from the American Journal of Human Genetics' “Genomic medicine year in review: 2024” paper.    Joining Kira Dineen for this discussion are two leaders in genomics: Dr. Bruce Gelb and Dr. Eric Green. In this reflective conversation, Kira Dineen, Dr. Bruce Gelb, and Dr. Eric Green discusses the significant developments in genetics and genomics over the past year, including the recent American Society of Human Genetics (ASHG) conference. They explore themes such as variable expressivity, the integration of genomics in human genetics, and the importance of diversity in genomic research.    The discussion also highlights key publications in genomic medicine and the evolving landscape of genetic research, emphasizing the need for continued focus on prevention and the implications of polygenic risk scores. They converse about the evolving landscape of genomic medicine, highlighting key advancements in research, particularly in areas like hemochromatosis and CRISPR technology. They reflect on the rapid progress made in genomic sequencing, especially in newborns, and the transformative impact it has on healthcare, particularly in NICUs. The discussion emphasizes the importance of diverse studies and scalable solutions in genetic counseling, as well as the future potential of genomic medicine to save lives and improve health outcomes.    Top 2024 Genomic Medicine Advancements Testing and managing iron overload after genetic screening-identified hemochromatosis Actionable genotypes and their association with lifespan in Iceland Impact of digitally enhanced genetic results disclosure in diverse families Chronic disease polygenic risk scores for clinical implementation in diverse US populations Skeletal Muscle Ryanodine Receptor 1 Variants and Malignant Hyperthermia Treating inherited retinal disease with gene-editing Validation of a clinical breast cancer risk assessment tool for all ancestries Broader access to clinical genome sequencing benefits diverse individuals with rare diseases Benefits for children with suspected cancer from routine whole-genome sequencing Clinical signatures of genetic epilepsies precede diagnosis in electronic medical records   The Guests:    Bruce D. Gelb, M.D. is the Director and Gogel Family Professor of the Mindich Child Health and Development Institute at the Icahn School of Medicine at Mount Sinai. He is Professor of Pediatrics and of Genetics and Genomic Sciences. Dr. Gelb completed a pediatric residency and pediatric cardiology fellowship at Babies Hospital of Columbia-Presbyterian Medical Center and Texas Children's Hospital at the Baylor College of Medicine, respectively. He joined the faculty at Mount Sinai in 1991 after fellowship and has remained there since. He developed and now oversees an extensive program in genomics/gene discovery for congenital heart disease. Dr. Gelb has received the E. Mead Johnson Award from the Society for Pediatric Research and the Norman J. Siegel New Member Outstanding Science Award from the American Pediatric Society. He was elected to the American Society of Clinical Investigation and the National Academy of Medicine (formerly, the Institute of Medicine). Dr. Gelb is the President for the American Pediatric Society, Immediate Past President for the International Pediatric Research Foundation and Treasurer-Elect for the American Society of Human Genetics. In addition to his research, he co-directs the Cardiovascular Genetics Program at Mount Sinai.   Dr. Eric Green is the director of the National Human Genome Research Institute (NHGRI) at the U.S. National Institutes of Health (NIH). As NHGRI director, Dr. Green leads the Institute's research programs and other initiatives. He has played an instrumental leadership role in developing many high-profile efforts relevant to genomics. Dr. Green received his B.S. degree in bacteriology from the University of Wisconsin - Madison in 1981, and his M.D. and Ph.D. degrees from Washington University in 1987. Coincidentally, 1987 was the same year that the word “genomics” was coined. Dr. Green's relationship with the Institute began long before his appointment as director. He served as the Institute's scientific director (2002 - 2009), chief of the NHGRI Genome Technology Branch (1996 - 2009) and founding director of the NIH Intramural Sequencing Center (1997 - 2009). Prior to that, he played an integral role in the Human Genome Project. Dr. Green is a founding editor of the journal Genome Research (1995 - present) and a series editor of Genome Analysis: A Laboratory Manual (1994 - 1998), both published by Cold Spring Harbor Laboratory Press. He is also co-editor of Annual Review of Genomics and Human Genetics (since 2005). Throughout his career, he has authored and co-authored over 385 scientific publications.    Dr. Green is a recurring guest on DNA Today, and he might hold the title as the guest who has been on the show the most times! He was featured on Episode #182 when we chatted about the Human Genome Project and the recent completion of the human genome sequence -- from telomere to telomere. Dr. Green was a panelist on the PhenoTips Speaker Series installment that our host Kira Dineen moderated about population genomics in clinical practice, this was also released on the DNA Today podcast feed as Episode #260. He was also on the last couple years for our genetics wrapped 2022 (#214) and 2023 (#263).    Be sure to subscribe to DNA Today wherever you get your podcasts to explore hundreds of episodes on topics ranging from genetic counseling to cutting-edge research in genomics. New episodes are released every Friday. In the meantime, you can binge over 300 other episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “DNA Today”. Episodes since 2021 are also recorded with video which you can watch on our YouTube channel, this includes some episodes recorded at NBC Universal Stamford Studios.    DNA Today is hosted and produced by Kira Dineen. Our video lead is Amanda Andreoli. Our social media lead is Kajal Patel. Our Outreach Intern is Liv Davidson. And our logo Graphic Designer is Ashlyn Enokian, MS, CGC.    See what else we are up to on Instagram, X (Twitter), Threads, LinkedIn, Facebook, YouTube and our website, DNAToday.com. Questions/inquiries can be sent to info@DNAtoday.com. 

In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.   Social Media to follow  Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you can be successful and already know some issues that you may encounter as a Startup  Who is Adnan Asfaq?  Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Adnan Ashfaq LinkedIn: https://www.linkedin.com/in/adnan-ashfaq-44478121/ Simplimedica website: https://simplimedica.com   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD.  Who is Maria Diez?  María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD).  Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María's passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323  CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/  PCCP guidance US:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you'll see that it is not so obvious. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.  Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/  SMDC website: https://www.smdc.ch  IEC 60601-1-8 Alarm System: https://webstore.iec.ch/en/publication/59648 Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/  Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg  ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked  Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.  Who is Rod Beuzeval?  Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance  Leap Compliance website: www.leapcompliance.com  ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019  Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U  Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/  eQMS for Risk Management: https://eqms-smarteye.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Dr. Brian Kim is an award winning dermatologist and researcher known as The ItchDoctor. His groundbreaking research has led to patents in itch molecules and he uses his platform to educate the public about different causes of itching. On this episode of the Vault we discuss how men and women experience itch differently and ways that skin and hair impact mental health.Dr. Kim received his M.D. from the University of Washington, was a HHMI-NIH Scholar, completed residency in dermatology at the University of Pennsylvania where he earned a Master of Translational Research (MTR). The Kim Lab focuses on mechanisms that underlie skin inflammation and the sensation of itch as a fundamental, broad, model paradigm of neuroimmunology. Key discoveries include the first identification of group 2 innate lymphoid cells (ILC2s) in the skin of both mice and humans, novel contributions of basophils, ILC2s, and natural killer (NK) cells to skin inflammation, and unveiling how immune cells and type 2 cytokines/JAK signaling directly influence sensory neuronal responses. He has peer-reviewed publications, multiple NIH grants, designed pivotal clinical trials that led to novel FDA-approved treatments, and is an inventor of itch-centered technologies. His research has led to awards and funding from NIH, Doris Duke Charitable Foundation, American Skin Association, American Academy ofDermatology, American Society for Clinical Investigation, American Dermatological Association, and International League of Dermatological Societies. He holds a patent for the use of JAK inhibitors for chronic itch. He is on the scientific advisory board for Abrax Japan, Granular Therapeutics, Recens Medical, National Eczema Association, and Cell Reports Medicine. He is on the editorial board of Journal of Allergy and Clinical Immunology, section editor for Journal of Immunology and on the board of rev How Intimacy Health I related to Mental health Myths about Intimacy health. How to identify signs of High Functioning Depression High Functioning Depression in Healthcare workers Anhedonia How to cope with High Functioning Depression

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice.  Who is Stefan Bolleininger?   Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/  BeOnQuality Website: https://www.be-on-quality.com/  MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf  MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf  EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/  Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation  eQMS for Medical Devices: https://eqms-smarteye.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Military Medicine & WarDocs present: "A Ready Medical Force Special Collection." Episode Summary:    What transformations can occur when cutting-edge medical research meets the urgency of combat scenarios? This episode of WarDocs takes you on an enlightening exploration with US Air Force Colonel Dr. Joe Maddry, a distinguished figure in military medicine. We unravel the complexities of combat casualty aeromedical evacuation as Dr. Maddry, a lead author on a pivotal study published in the AMSIS Journal of Military Medicine, shares insights from his extensive career—from the Air Force Academy to his current role at the BAMC Department of Clinical Investigation. Discover how his work is charting new paths in the management of patient transfers between Role 2 and Role 3 medical facilities, especially in the fast-paced environment of combat zones. Dr. Maddry and his co-authors spotlight the "Golden Hour Rule" and its implications during Operation Enduring Freedom. This in-depth conversation covers how their research addresses the care provided during critical inter-facility transports and compares it to previous studies on point-of-injury evacuations. Learn how their findings could shape future military medical protocols and improve patient outcomes in the theater of war. This episode is a must-listen for anyone interested in the advancements and challenges of military healthcare, offering a comprehensive look into the strategic evolution of aeromedical evacuations.   AMSUS Military Medicine Article Reference: Management of Combat Casualties during Aeromedical Evacuation from a Role 2 to a Role 3 Medical Facility Joseph K Maddry, MD, USAF, MC et al. Military Medicine, Volume 189, Issue 5-6, May/June 2024, Pages e1003–e1008, https://doi.org/10.1093/milmed/usad404     Take Home Messages: Transformative Approaches in Military Medicine: The episode highlights significant advancements in military medical evacuations, focusing on the transition of patient care from Role 2 to Role 3 medical facilities. The discussion provides insights into the complexities of managing combat casualties and the innovations that are reshaping operational medicine. Golden Hour Rule Reevaluation: The podcast explores the "Golden Hour Rule" implemented during Operation Enduring Freedom, examining its impact on patient transport logistics and outcomes. The findings suggest a need to adapt and refine evacuation procedures to enhance efficiency and patient survival rates. Complexity of Inter-Facility Transports: A major takeaway is the higher complexity involved in inter-facility transports compared to initial evacuations from the point of injury. The study underscores the importance of having advanced medical providers and equipment to handle critical interventions during these longer transport durations. Training and Resource Implications: The episode emphasizes the need for improved training and resource allocation to prepare military medical teams for future conflicts. It suggests expanding the skill set of medics and incorporating advanced technology to support the demanding requirements of patient transfers. Strategic Planning for Future Conflicts: The conversation sheds light on the strategic considerations necessary for future military operations, particularly in scenarios with limited air security. It calls for innovative solutions in ground and air transport capabilities to ensure effective care for large volumes of post-operative patients.   Episode Keywords: US Air Force, Colonel, Dr. Joe Maddry, Military Medical Research, Combat Casualty Aeromedical Evacuation, BAMC, Department of Clinical Investigation, Emergency Medicine, Patient Transfer Management, Role 2, Role 3, Medical Facilities, Air Force Academy, Military Medicine, AMSIS Journal, Operation Enduring Freedom, In-Theater Inter-Facility Patient Transports, Evacuation Procedures, Patient Outcomes, Operational Medicine, Military Healthcare Advancements   Hashtags: #MilitaryMedicine #CombatCasualtyCare #AeromedicalEvacuation #GoldenHour #WarDocsPodcast #JoeMaddry #MilitaryHealthcare #EmergencyMedicine #OperationalMedicine #MilitaryInnovation   Honoring the Legacy and Preserving the History of Military Medicine The WarDocs Mission is to honor the legacy, preserve the oral history, and showcase career opportunities, unique expeditionary experiences, and achievements of Military Medicine. We foster patriotism and pride in Who we are, What we do, and, most importantly, How we serve Our Patients, the DoD, and Our Nation. Find out more and join Team WarDocs at https://www.wardocspodcast.com/ Check our list of previous guest episodes at https://www.wardocspodcast.com/our-guests Subscribe and Like our Videos on our YouTube Channel: https://www.youtube.com/@wardocspodcast Listen to the “What We Are For” Episode 47. https://bit.ly/3r87Afm WarDocs- The Military Medicine Podcast is a Non-Profit, Tax-exempt-501(c)(3) Veteran Run Organization run by volunteers. All donations are tax-deductible and go to honoring and preserving the history, experiences, successes, and lessons learned in Military Medicine. A tax receipt will be sent to you. WARDOCS documents the experiences, contributions, and innovations of all military medicine Services, ranks, and Corps who are affectionately called "Docs" as a sign of respect, trust, and confidence on and off the battlefield,demonstrating dedication to the medical care of fellow comrades in arms.     Follow Us on Social Media Twitter: @wardocspodcast Facebook: WarDocs Podcast Instagram: @wardocspodcast LinkedIn: WarDocs-The Military Medicine Podcast YouTube Channel: https://www.youtube.com/@wardocspodcast

Episode 179: Impact of intermittent fasting Impact on T2DMFuture Dr. Carlisle explains the physiology of fasting and how it can help revert type 2 diabetes. Dr. Arreaza adds details on how to do intermittent fasting. Written by Cameron Carlisle, MSIV, Ross University School of Medicine. Comments and edits by Hector Arreaza, MD, FAAFP.You are listening to Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California, a UCLA-affiliated program sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. This podcast was created for educational purposes only. Visit your primary care provider for additional medical advice.What is type 2 Diabetes Mellitus (T2DM)?-Type 2 Diabetes Mellitus (T2DM) is a metabolic disorder characterized by insulin resistance and impaired glucose regulation. -This impaired regulation can lead to hyperglycemia, contributing to complications in a myriad of organs: heart, kidneys, eyes, nerves, etc. (target organs). According to the CDC, more than 38 million Americans have T2DM (about 1/10 people). -Multiple mechanisms are believed to contribute to insulin resistance in obese patients with T2DM, such as increased lipid deposition throughout the body and systemic inflammation.What is Intermittent Fasting (IF)? Intermittent fasting (IF) has recently gained popularity as a dietary approach for health benefits, but it has been around for thousands of years. IF is an eating pattern that alternates between eating and fasting (no calories consumed) over a specific period of time. When you are fasting, you are allowed and encouraged to keep drinking water and non-caloric drinks, like coffee, tea, and even homemade bone broth.-According to the International Food Information Council Foundation (IFIC), 10% of Americans engage in IF daily. -According to Mark Mattson, a neuroscientist and IF expert for over 25 years, a mechanism called “metabolic switching” is seen with IF. This is when your body runs out of glucose and starts burning fat (i.e., fatty oxidation). These metabolic changes can help protect your organs and reduce the risk of chronic conditions, like T2DM. Common IF methods: Time-restricted eating: Most common method, involves eating within a specific time frame (e.g., the 16:8, 18:6, 12:12 method is also common.  [16:8 means you have 16 hours of fasting and 8 hours of eating.]Alternate-day fasting: Alternating between fasting days and normal eating days.  [Find more info in The Complete Guide to Fasting, by Jason Fung, who is a nephrologist, he explains that alternate-day is basically eating every other day, which would give 36 hours of fasting, but if you are a beginner you can try a 24 hours fasting, in short, not eating breakfast any day of the week and having lunch 4 days a week, and dinner every night.]5:2 diet (aka periodic fasting): Maintaining a normal diet for 5 days, with 2 days (usually non-consecutive) of caloric restriction (25% of normal caloric intake; e.g., 500 calorie meal). IF is strongly believed to improve metabolic health in individuals with T2DM by reducing insulin resistance via increasing insulin sensitivity, promoting weight loss (patients with obesity and DM… AKA patients with diabesity), and enhancing lipolysis via fat oxidation.While fasting, the body goes through several phases that affect how energy is metabolized. Between 0 and 4 hours after eating, the body enters a feeding state, using glucose as its main energy source. After fasting for 12-16 hours, the body enters ketosis and starts to use fat for energy. Within 24-36 hours, autophagy begins, a process that recycles damaged cells and allows for cellular repair. This process can have great benefits for people with T2DM, such as improved insulin sensitivity and glucose regulation. Pathophysiology of Implementing IF in T2DM. -IF is thought to increase insulin sensitivity by decreasing fatty tissue in the body (i.e., visceral adipose tissue), which is correlated to insulin resistance. Insulin resistance is defined as higher than normal circulating insulin levels needed for a glucose lower response, which is thought to be the culprit for the generation of T2DM. It means you need high levels of insulin to keep glucose normal. -Obesity is an important risk factor for T2DM. Visceral adipose tissue functions as an organ via the secretion of adipokines (cytokines or cellular messengers produced by adipose tissue): leptin and adiponectin. Leptin: proinflammatory, leading to chronic inflammation. Patients with higher BMI levels and increased insulin resistance were found to have increased leptin levels.[Leptin is a good hormone at normal levels, but there is leptin resistance] Adiponectin: anti-inflammatory and antidiabetic effects. Higher adiponectin levels result in decreased hepatic gluconeogenesis, enhanced glucose absorption, and enhanced skeletal muscle and hepatic fatty acid oxidation. Levels drop as visceral fat increases. -Dr. López-Jaramillo, a Colombian endocrinologist and researcher, and colleagues published a review in 2014 examining the imbalance in the levels of leptin and adiponectin in individuals with metabolic syndrome. This imbalance (increase in leptin and decrease in adiponectin) is linked to obesity and insulin resistance, which has been shown to increase the risk of T2DM. It has been shown that IF has resulted in the reduction of leptin levels and increased levels of adiponectin, which leads to decreased insulin resistance and increased insulin sensitivity. -IF allows pancreatic beta-cells to rest by not having to secrete insulin constantly. This allows the beta-cells of the pancreas to improve in function over time. In addition, IF has been shown to lead to noticeable weight loss and loss in body fat, both of which play an important contribution in managing T2DM. Research demonstrates that this weight loss increases insulin sensitivity and decreases the need for insulin therapy, making IF a powerful approach for improving metabolic health. AMP-Activated Protein Kinase (AMPK) and Its Role in IF and T2DM Recent research has highlighted an important enzyme seen in IF, AMP-activated protein kinase (AMPK), which plays a vital role as an important energy sensor in cells. It is activated when cellular energy levels are low, such as during IF. A 2020 research study in Nature Reviews Endocrinology explains that activation of AMPK aids in suppressing gluconeogenesis and stimulates fatty acid oxidation, leading to optimal energy balance and reduction of visceral adipose tissue accumulation, a major contributor to insulin resistance and T2DM progression. AMPK is upregulated during fasting, which enhances glucose metabolism and reduces insulin resistance. This is imperative in managing T2DM, as it counters the effects of insulin resistance associated with T2DM.Exercise, which also promotes AMPK activation, complements IF and can promote a synergistic effect in improving insulin sensitivity and promoting fat burning, New Research Findings on IF and T2DM -The EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized clinical trial published in JAMA Network Open (2024). Findings In this randomized clinical trial study found that a time-restricted eating window significantly improved fasting glucose levels and HbA1c levels in individuals with T2DM. The study examined the effect of a 16-week 5:2 meal replacement (5:2 MR) fasting plan that consisted of five days of normal eating and 2 days, nonconsecutive of restricted diet (500-600 calories). This group was examined alongside a group of patients who took metformin 0.5 g BID and empagliflozin 10 mg QD. The study wanted to investigate the changes in HbA1c in Chinese adults with early T2DM.-The study was a randomized clinical trial of 405 adults, and a study showed that the 5:2 MR approach led to better glycemic control at 16 weeks compared to the counter treatments with metformin and empagliflozin. The 5:2 MR group had the greatest reduction in HbA1c (-1.9%), followed by metformin (-1.6%), and empagliflozin (-1.5%). The 5:2 MR plan also revealed the greatest weight loss (-9.7 kg), followed by empagliflozin (-5.8 kg), and metformin (-5.5 kg). -This research suggests IF, such as 5:2 MR, can be a powerful tool in the management of T2DM and improving metabolic health. This study can potentially open doors for healthcare providers to provide the 5:2 MR approach for individuals as an effective initial lifestyle intervention. However, follow-up studies are needed to assess the effectiveness and durability of the 5:2 MR.Safety and Risks of IF in T2DM. -IF when combined with glucose-lowering medications (e.g., insulin, sulfonylureas, GLP-1 agonists) can increase the risk of hypoglycemia. Also, prolonged fasting can lead to nutrient deficiencies if not planned carefully. Patients should be counseled on maintaining a balanced, nutritious diet during non-fasting days. -IF is not suitable for everyone. Children under the age of 18 should not try IF due to needing proper calories for adequate development and proper growth. Also, it is recommended that pregnant or breastfeeding women do not undergo IF. It is advised that people with eating disorders should not try IF. -Individuals with certain medical conditions, such as kidney stones or gastroesophageal disease should speak with their doctor before trying IF. Also, patients on insulin or other glucose-lowering medications should adjust their dose and talk with their healthcare providers to prevent hypoglycemia during fasting. It is recommended that each person speak with their doctor to discuss the safety and risks of IF and see if it would benefit the individual before starting IF. -Many studies have explored the benefits of IF at the micro level revealing its cellular benefits and on a macro level of the body as a whole. However, more research is needed to confirm the long-term effects of IF on glycemic control and its sustainability as a therapeutic approach for T2DM. Conclusion:-IF shows potential for improving glycemic control, promoting weight loss, and enhancing metabolic health in individuals with T2DM. Despite its benefits, IF may present with risks, such as hypoglycemia, nutrition deficiencies, or dehydration in certain patients. Therefore, it may not be suitable for all individuals. It's important to monitor patients who engage in IF, especially for patients with T2DM. Patients should follow up with their doctor for individualized IF plans in patients with T2DM. ______________This week we thank Hector Arreaza and Cameron Carlisle. Audio editing by Adrianne Silva.Even without trying, every night you go to bed a little wiser. Thanks for listening to Rio Bravo qWeek Podcast. We want to hear from you, send us an email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! _____________________References:Albosta, Michael, and Jesse Bakke. “Intermittent Fasting: Is There a Role in the Treatment of Diabetes? A Review of the Literature and Guide for Primary Care Physicians - Clinical Diabetes and Endocrinology.” BioMed Central, BioMed Central, 3 Feb. 2021, doi.org/10.1186/s40842-020-00116-1.Blumberg, Jack, et al. “Intermittent Fasting: Consider the Risks of Disordered Eating for Your Patient - Clinical Diabetes and Endocrinology.” BioMed Central, BioMed Central, 21 Oct. 2023, https://clindiabetesendo.biomedcentral.com/articles/10.1186/s40842-023-00152-7.De Cabo, Rafael, and Mark P. Mattson. “Effects of intermittent fasting on health, aging, and disease.” New England Journal of Medicine, vol. 381, no. 26, 26 Dec. 2019, pp. 2541–2551, https://doi.org/10.1056/nejmra1905136.Guo, Lixin, et al. “A 5:2 intermittent fasting meal replacement diet and glycemic control for adults with diabetes.” JAMA Network Open, vol. 7, no. 6, 21 June 2024, https://doi.org/10.1001/jamanetworkopen.2024.16786.Herz, Daniel, et al. “Efficacy of Fasting in Type 1 and Type 2 Diabetes Mellitus: A Narrative Review.” Nutrients, U.S. National Library of Medicine, 10 Aug. 2023, www.ncbi.nlm.nih.gov/pmc/articles/PMC10459496/. Herzig, S., & Shaw, R. J. (2018). AMPK: Guardian of metabolism and mitochondrial homeostasis. Nature Reviews Molecular Cell Biology, 19(2), 121-135.Longo, V. D., & Mattson, M. P. (2014). Fasting: Molecular mechanisms and clinical applications. Cell Metabolism, 19(2), 181-192. https://doi.org/10.1016/j.cmet.2013.12.008López-Jaramillo P, Gómez-Arbeláez D, López-López J, et al. The role of leptin/adiponectin ratio in metabolic syndrome and diabetes. Hormone Molecular Biology and Clinical Investigation. 2014;18(1):37–45.Mattson, Mark P., et al. “Impact of intermittent fasting on health and disease processes.” Ageing Research Reviews, vol. 39, Oct. 2017, pp. 46–58, https://doi.org/10.1016/j.arr.2016.10.005. Patikorn, Chanthawat, et al. “Intermittent fasting and obesity-related health outcomes.” JAMA Network Open, vol. 4, no. 12, 17 Dec. 2021, https://doi.org/10.1001/jamanetworkopen.2021.39558.Sharma, Suresh K, et al. “Effect of Intermittent Fasting on Glycaemic Control in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.” TouchREVIEWS in Endocrinology, U.S. National Library of Medicine, May 2023, www.ncbi.nlm.nih.gov/pmc/articles/PMC10258621/#:~:text=In%20IF%2C%20eating%20habits%20are,the%20risk%20of%20developing%20T2DM.Xiaoyu, Wen, et al. “The effects of different intermittent fasting regimens in people with type 2 diabetes: A network meta-analysis.” Frontiers in Nutrition, vol. 11, 25 Jan. 2024, https://doi.org/10.3389/fnut.2024.1325894. Theme song, Works All The Time by Dominik Schwarzer, YouTube ID: CUBDNERZU8HXUHBS, purchased from https://www.premiumbeat.com/.

in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.  Who is Georg Digel?  I've reviewed too many Medical Device CAPAs over the last 10 years. I think I've seen almost every mistake there is ...Some of my "favorites": - Initiating CAPA without gathering facts - Setting up KPIs but not monitoring them - Confusing Correction with Corrective Action To be honest - I've made many of these mistakes myself. Luckily, I learned and improved. Over time, I even took on bigger responsibilities. Some projects which I really enjoyed: - Process harmonizations for 60 sites - Setup of training programs for 1.000+ people - KPI dashboard implementations for 813 CAPAs My learnings were paired with painful experiences. I want to save you from all of them. My goal is to help you: 1. Avoid CAPA related audit findings or 483s 2. Implement meaningful metrics for your CAPAs 3. Train your people so they close records effectively Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Georg Digel LinkedIn: https://www.linkedin.com/in/georgdigel/  Vincent Cafiso Podcast episode: Are you More Corrections or Corrective Actions or Preventive actions? https://www.youtube.com/watch?v=YsXfBv_AdWc  How to be the best at CAPAs with Karandeep Badwal: https://www.youtube.com/watch?v=zWK1U7d2awY  Most important issues on CAPAs: https://www.youtube.com/watch?v=lR4r14V5oHA  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and material compliance. He has experience as a material expert in ISO 13485 certified companies of several years, he knows the requirements the MDR makes towards medical devices and can translate these into material requirements. He has lead multiple projects on an international level successfully for topics like material change-overs, IP, bio compatibility and second source material qualification. He is a self driven, communicative and assertive person, he loves challenges and he strives always for self improvement. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Lucas Pianegonda LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/?locale=en_US Gradical website: https://gradical.ch/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Dr. Will Bulsiewicz, affectionately known as "Dr. B," is a distinguished gastroenterologist, globally renowned gut health authority, and a bestselling author of "Fiber Fueled" and "The Fiber Fueled Cookbook" recognized by the New York Times, Wall Street Journal, and USA Today. He is an Adjunct Assistant Professor of Medicine at Emory School of Medicine and the visionary Founder of 38TERA, a leading gut health supplement company.Dr. B is dedicated to democratizing health knowledge as the U.S. Medical Director of ZOE. His scholarly work includes over twenty articles in top-tier scientific journals like Nature Medicine, and he has delivered more than forty presentations at national forums, including sessions with Congress and the USDA. He has educated over 10,000 students on enhancing gut health.His academic credentials include a Bachelor's degree from Vanderbilt University, a medical degree from Georgetown University, and a Master's in Clinical Investigation from Northwestern University. Dr. B was the chief medical resident at Northwestern and the chief gastroenterology fellow at The University of North Carolina, and received the highest award given by both his residency and fellowship. He completed an epidemiology fellowship on a grant from the National Institutes of Health at UNC's prestigious Gillings School of Global Public Health.Dr. B resides in Charleston, South Carolina with his family. Connect with him on Instagram and Facebook at @theguthealthmd, on TikTok at @theguthealthmd_, or visit his website at theplantfedgut.com to join his free email list explore more about his work and insights on gut health.www.theplantfedgut.comhttps://www.facebook.com/theguthealthmd/https://www.instagram.com/theguthealthmd/https://www.tiktok.com/@theguthealthmdThank you so much for listening! I use fitness and movement to help women prevent and overcome pelvic floor challenges like incontinence and organ prolapse. There is help for women in all life stages! Every Woman Needs A Vagina Coach! Please make sure to LEAVE A REVIEW and SUBSCRIBE to the show for the best fitness and wellness advice south of your belly button. *******************I recommend checking out my comprehensive pelvic health education and fitness programs on my Buff Muff AppYou can also join my next 28 Day Buff Muff Challenge https://www.vaginacoach.com/buffmuffIf you are feeling social you can connect with me… On Facebook https://www.facebook.com/VagCoachOn Instagram https://www.instagram.com/vaginacoach/On Twitter https://twitter.com/VaginaCoachOn The Web www.vaginacoach.comGet your Feel Amazing Vaginal Moisturizer Here

They say age is just a number…and no concept drives this point home more than biological age. You see, your chronological age isn't the same as the age of your cells. That's why you can have people who look younger (or older) than their stated age.   This has a lot to do with Plasminogen activator inhibitor-1 or PAI-1.   People age at different rates and there are conditions and circumstances that make some age more rapidly than others. From climate, diet, stress and genetics, there are so many factors that impact the health of our cells.   Here's the good news: how long we've been on the planet doesn't have to dictate our health and wellness. There are proactive steps we can take to extend not just the span of our lives but its quality too.   What is plasminogen activator inhibitor-1 and how does it affect aging? Why is there a difference between chronological age and biological age? What can we learn from communities and locations that have longevity?   In this episode, I'm joined by the chairman of the Department of Medicine at Northwestern University, and leader of the Potocsnak Longevity Institute, Dr. Douglas Vaughan. He talks about the strides we've made in understanding biological age and what we can do about it.  Things You'll Learn In This Episode    -The biggest driver of biological age People's biological age can be higher or lower than their stated chronological age. What is plasminogen activator inhibitor-1 (PAI-1) and how does it impact this?    -How to slow aging Every choice we make either ages us faster or it slows down the aging process. How do we make choices that support longevity?    -A convergence of scientific strides We're in the golden age of understanding biological aging. What strides have been made to deepen our knowledge and discover interventions?   Guest Bio   Dr. Douglas E. Vaughan, is chairman of the Department of Medicine and the Irving S. Cutter Professor of Medicine in the Division of Cardiology at Northwestern University Feinberg School of Medicine. He is a fellow of the American College of Cardiology and has been elected to membership in the American Society for Clinical Investigation and the Association of American Physicians. In 2018, Dr. Vaughan led a study that reported the first genetic variation that appears to protect against multiple aspects of biological aging in humans in an extended kindred of Old Order Amish living in the vicinity of Berne, Indiana.   Dr. Vaughan now leads the recently launched Potocsnak Longevity Institute, bringing together scientists and experts across many disciplines to study those populations that seem resistant to negative consequences of aging with a goal of discovering what makes them unique. With a deeper understanding of how aging works, the institute aims to expand the healthspan for all people with future therapies and lifestyle interventions. To learn more, visit https://www.feinberg.northwestern.edu/sites/longevity/index.html.    About Your Host   Hosted by Dr. Deepa Grandon, MD MBA, triple board-certified physician with over 23 years of experience working as a Physician Consultant for influential organizations worldwide. Dr. Grandon is the founder of Transformational Life Consulting (TLC) and an outspoken faith-based leader in evidenced-based lifestyle medicine.   Disclaimer    ​​TLC is presenting this podcast as a form of information sharing only. It is not medical advice or intended to replace the judgment of a licensed physician. TLC is not responsible for any claims related to procedures, professionals, products, or methods discussed in the podcast, and it does not approve or endorse any products, professionals, services, or methods that might be referenced.   Check out this episode on our website, Apple Podcasts, or Spotify, and don't forget to leave a review if you like what you heard. Your review feeds the algorithm so our show reaches more people. Thank you!

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.  Who is Martin King?  Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.  Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.  Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/  QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2  QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Stephen O'Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field.  Who is Stephen O'Rourke?  Stephen O'Rourke, based in Berlin, Germany, is a seasoned regulatory affairs expert with extensive experience across the food, biotech, and medical device industries. With deep expertise in EU and global regulations, he is dedicated to helping companies navigate complex regulatory landscapes, ensuring the successful launch of innovative products. His journey and transition into medical device regulation began at one of Europe's largest clinics, where he was instrumental in kickstarting their MDR consultancy. Outside of his regulatory work, Stephen is an advocate for transparency and accountability in politics, having run for the European Parliament in 2024 to champion these causes. He is also actively involved in promoting Ireland's traditional sports and enjoys exploring Berlin with his family.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Stephen O'Rourke LinkedIn: https://www.linkedin.com/in/sorourkede/  AI Act Summit Link: https://medtechconf.com/event/ai-act-summit/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

This is the second part of our Wim Hof series; A comprehensive exploration of the Wim Hof Method. We unpack the transformative effects of this powerful technique on mental, physical, and spiritual health. Join us as we continue to explore controlled breathing, cold exposure, and their profound impacts, with expert interviews and actionable insights.Deepening Mental Clarity - Further examine how advanced breathing techniques can enhance cognitive functions.Advanced Physical Health Techniques - Dive into more sophisticated practices that amplify endurance and recovery.Elevating Emotional Resilience - Explore deeper emotional management strategies for a more balanced life.Integrating Spiritual and Interpersonal Growth - Learn how the Wim Hof Method fosters deeper connections with oneself and others.We reference ongoing research from prestigious journals such as the Journal of Neurophysiology, Journal of Clinical Investigation, and European Journal of Applied Physiology to enrich our discussions with scientifically backed insights.Breath - Wim Hof Documentary https://www.youtube.com/watch?v=C0RBMwirwC4With Gratitude xxx Hosted on Acast. See acast.com/privacy for more information.

In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We'll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… Who is Ralf Gansel? With over a decade of experience in the medical health sector and equipped with a subtly dry sense of humor, Ralf committed to bringing transformative medical technologies to the EU and global markets by leveraging his extensive expertise in regulatory frameworks and market dynamics. At TÜV SÜD in the Medical & Health Services Business Unit , Ralf head the Special Operations and Support department. He is specialized in onboarding and supporting new clients, dealing in the field of active and non-active devices, implantables, and IVDs. His role focuses on advancing technological innovations and ensuring their market success while meeting EU and international regulatory requirements. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Ralf Gansel LinkedIn: https://www.linkedin.com/in/ralf-gansel/ TÜV SÜD website: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly.  Who is Beat Keller?  Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/  SMDC website: https://www.smdc.ch  EU MDR harmonized standards: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en   EU IVDR harmonized standards: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en   Swiss harmonized standards: https://www.switec.info/de/neue-harmonisierte-normen/  US FDA Recognized Consensus Standards: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm 

Tina was 33 when she was diagnosed with breast cancer. She discovered a bumpnear her clavicle and went to her OGBYN who promptly sent her for a mammogram.Tina is among a growing number of young women being diagnosed with breast cancer. Tina's treatment started with six rounds of chemotherapy, followed by a double mastectomy earlier this summer. She is currently doing some rounds of low dosage chemotherapy throughout the rest of this year and recently started radiation treatment as well. Tina works as a Government Relations Manager and works in public policy forDoorDash. Tina loves to travel and goes to Ireland several times a year. Tina and herfiancé Erik also spend a lot of time on outdoor adventures with their dog, Buddy. Dr. Mayer received her medical degree from Harvard Medical School, completed aresidency in Internal Medicine at Brigham and Women's Hospital, and a fellowship inHematology/Oncology at Dana-Farber Cancer Institute. She obtained a Master's inPublic Health from the Harvard School of Public Health. She was awarded the 2023Canellos Award for Excellence in Clinical Investigation and Patient Care, the 2024Dana-Farber Clinical Innovation Award, and is a Boston Magazine “Top Doctor.”

Dr. Hahn is the William Rosenberg Professor of Medicine in the Department of Medical Oncology at Dana-Farber Cancer Institute and Harvard Medical School and an Institute Member of the Broad Institute of MIT and Harvard. He serves as an Executive Vice President and the Chief Operating Officer at the Dana-Farber Cancer Institute. Dr. Hahn has made numerous discoveries that have informed our currentmolecular understanding of cancer. His laboratory has pioneered the use of integrated functional genomic approaches to identify and validate cancer targets. The tools, models and approaches that his laboratory has developed are widely used worldwide to discover and validate molecularly targeted cancer therapies. Dr. Hahn has served as the President of the American Society for ClinicalInvestigation and has been elected to the Association of American Physicians and the National Academy of Medicine. Dr. Hahn has been the recipient of many honors and awards including the Wilson S. Stone Award from M.D. Anderson Cancer Center for outstanding research in cancer (2000), a Howard Temin Award from the National Cancer Institute (2001), the Ho-Am Prize in Medicine (2010), the Richard and Hinda Rosenthal Award from AACR (2015) and the Claire and Richard Morse Award (2019). He has been elected to the American Society of Clinical Investigation, American Association of Physicians, the National Academy of Inventors and the National Academy of Medicine.

The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now.  Who is Andreas Stange?  Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia. Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Andreas Stange Linkedin Profile: https://www.linkedin.com/in/andreasstange/  TÜV SÜD Website: https://www.axonlawyers.com/  EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

On today's special episode of Hot Topics and Kidney Health we're sharing audio from a recent webinar hosted by National Kidney Foundation on kidney xenotransplantation. Stay tuned to hear from the experts and learn about the latest updates on animal-to-human transplantation.   Dr. Tatsuo Kawai is a professor of surgery at Harvard Medical School and the A. Benedict Cosimi Chair in Transplant Surgery at Massachusetts General Hospital. He is also director of the Legorreta Center for Clinical Transplantation Tolerance. He was awarded the Martin Research Prize at MGH in 2009 and the New Key Opinion Leader Award by the Transplantation Society in 2010 for this work. In the field of xenotransplantation, he has collaborated extensively with eGenesis over the past five years, achieving over two years of survival for genetically edited kidney xenografts in nonhuman primates, which was published in Nature in 2023. In March 2024, he successfully performed the world first kidney xenotransplantation from the pig with 69 genomic edits in a living patient with end stage renal disease.  Vineeta Kumar MD, FAST, FASN  is the lead nephrologist for the Living Kidney Donor and Incompatible Kidney Transplant programs at the University of Alabama in Birmingham. She is an expert in kidney transplantation, living kidney donation, incompatible kidney transplant, kidney paired donation and cardiovascular outcomes after kidney transplantation. Peter Reese, MD, PhD, is an NIH-funded transplant nephrologist and epidemiologist. His research focuses on: a) developing effective strategies to increase access to solid organ transplantation; b) improving the process of selecting and caring for living kidney donors; c) determining outcomes of health policies on vulnerable populations with renal disease, including the elderly; d) testing strategies to improve important health behaviors such as medication adherence; and e) transplant ethics. He was a recipient of a Presidential Early Career Award for Scientists and Engineers, was elected member of the American Society of Clinical Investigation, and was a Greenwall Faculty Scholar in bioethics. He is a past chair of the Ethics Committee for the United Network for Organ Sharing (UNOS), which oversees organ allocation and transplant regulation in the US, and is an Associate Editor for the American Journal of Kidney Diseases. He co-led the THINKER, USHER, MYTHIC, and SHELTER trials involving transplanting HCV-infected donor organs into uninfected recipients. His work has been generously funded by foundations and the NIH, including a K-24 to support mentoring.   Do you have comments, questions, or suggestions? Email us at NKFpodcast@kidney.org. Also, make sure to rate and review us wherever you listen to podcasts.  

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more.  Who is Erik Vollebregt?  Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”   Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ Axon Lawyers Website: https://www.axonlawyers.com/  EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320  Medical devices: Council adopts new measures to help prevent shortages    https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf  Article Judith de Wildth – How to prepare for article 10a: https://www.linkedin.com/posts/erikvollebregt_how-to-prepare-for-article-10a-mdr-as-a-manufacturer-activity-7216378083308646401-vqzF  EUDAMED roll-out timeline: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Dr. Michael Diamond is an ID-trained physician scientist at Washington University of Saint Louis where he serves as the Herbert S. Gasser Professor within the Departments of Medicine, Molecular Microbiology, Pathology & Immunology.    Dr. Diamond runs a prolific basic science lab studying the molecular basis of disease of globally emerging RNA viruses and focuses on the interface between pathogenesis and host immunity. He is also actively involved in mentorship of physician-scientist trainees. He is also a recipient of Stanley J. Korsmeyer Award of the American Society of Clinical Investigation and currently an elected Councilor for the Association of American Physicians.     Dr. Diamond completed his MD/PhD training at Harvard University, after which he completed his postgraduate clinical training in medicine and infectious diseases at UCSF.    In today's episode, Dr. Diamond discusses the importance of high-quality research and its role in defining one's reputation. He also discusses the leaky pipeline and potential strategies to address the challenges associated with length of training and ways to improve mentorship including formal strategies to facilitate guided mentorship involving junior faculty.    Our thanks to Dr. Diamond for being on the podcast.     Lab website:    Related Links:  https://infectiousdiseases.wustl.edu/people/michael-s-diamond/  https://profiles.wustl.edu/en/persons/michael-diamond    Executive Producers:  -       Bejan Saeedi  -       Joe Behnke  -       Michael Sayegh  -       Carey Jansen  -       Nielsen Weng  Faculty Advisors   -       Brian Robinson  -       Mary Horton  -       Talia Swartz  -       Chris Williams  -       David Schwartz  Twitter: @behindthescope_  Instagram: @behindthemicroscopepod  Facebook: @behindthemicroscope1  Website: behindthemicroscope.com  

Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this.   Who is Ahmed Hendawy? Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape. Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed's strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region. In summary, Ahmed's leadership and Registitute's unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Links from the Video Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a Registitute LinkedIn: https://www.linkedin.com/company/registitute/ Registitute Website : www.registitute.com AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines for its implementation. Spoiler Alert ! first is August 2024 so be quick.  Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.    Links from the Video Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/  Axon Lawyers Website: https://www.axonlawyers.com/  EU Battery Regulation: https://data.consilium.europa.eu/doc/document/ST-10488-2023-INIT/en/pdf   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

You don't know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy. Who is Richie Christian? Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master's degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer. In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan. Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software.    Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links ·      Richie Christian Linkedin Profile: https://www.linkedin.com/in/christianrichie/ ·      Wega Website:  https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance ·      AAMI/BS standard https://knowledge.bsigroup.com/products/application-of-iso-14971-to-machine-learning-in-artificial-intelligence-guide?version=standard ·      Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles ·      Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice  

Dr. Kim Waddell is an Assistant Professor in Physical Medicine and Rehabilitation at the University of Pennsylvania's Perelman School of Medicine as well as a faculty member with the Center for Health Incentives and Behavioral Economics, a Senior Fellow in the Leonard Davis Institute of Health Economics, and Research and Innovation Manager in the Penn Medicine Nudge Unit at the University of Pennsylvania. In addition, Kim is a Research Health Scientist at the VA Center for Health Equity Research and Promotion. Kim's research focuses on behavior change and how to help motivate people to make decisions that are more aligned with their longer term goals. She is particularly interested in physical activity and using approaches from behavioral science to motivate adults who have had a stroke or have Parkinson's disease to increase their daily activity. Another area that Kim is interested in is designing clinical decision support systems and ways to improve decision making to make sure that people are getting the right amount of the right kind of rehabilitation after stroke. When she's not working, Kim tries to go running as often as possible to clear her head and disconnect from technology. She also enjoys cooking, particularly trying new recipes, as well as watching local sports teams and traveling. Kim received her BS in Health Science from Truman State University and her Master's degree in Occupational Therapy from the University of North Carolina at Chapel Hill. She then attended Washington University in St. Louis where she earned her PhD in Movement Science and her Master's degree in Clinical Investigation. Kim conducted postdoctoral research at the VA and Penn before joining the faculty there. Recently, she was awarded the 2024 Academy of Behavioral Medicine Research's Early-Stage Investigator Award, and in our interview, she shares more about her life and science.

Dr. Adam Gazzaley is a Professor of Neurology, Physiology and Psychiatry and the Founding Director of the Neuroscience Imaging Center at the University of California, San Francisco. Adam is also Co-Founder and Chief Science Advisor of Akili Interactive Labs, a company that is developing therapeutic video games. Much of the research in Adam's lab focuses on aging and how aspects of cognition, like memory and attention, change over our lifespan. They are working to develop new, innovative tools, including engaging video games, to enhance brain function, improve cognition, and improve quality of life. In his free time, Adam can be found spending quality time with friends and family. He is a fan of hanging out over dinner, enjoying live music, hiking, camping, and getting outdoors. He received his M.D. And Ph.D. in Neuroscience at the Mount Sinai School of Medicine. Adam then completed his Internship in Medicine and Clinical Residency in Neurology at the University of Pennyslvania, followed by postdoctoral training in Cognitive Neuroscience at UC, Berkeley before joining the faculty at UCSF where he is today. Adam is the recipient of the Pfizer/AFAR Innovations in Aging Award, the Ellison Foundation New Scholar Award in Aging, the Harold Brenner Pepinsky Early Career Award in Neurobehavioral Science, and the UCSF 150th Anniversary Alumni Excellence Award. He is also an elected Member of the American Society for Clinical Investigation. Adam is here with us today to tell us all about his journey through life and science.