Podcasts about Quality management system

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

ISO consultancy isn't a field many aspire to enter, mostly because many don't know it exists until you're tasked with either managing an existing ISO Management System or implementing a brand new one.  We're continuing with our latest mini-series where we introduce members of our team, to explore how they fell into the world of ISO and discuss the common challenges they face while helping clients achieve ISO certification.   In this episode we introduce Sarah Ball, a Senior Isologist® at Blackmores, to learn about her journey towards becoming an ISO Consultant and what drives her to help clients on their ISO journey.   You'll learn ·      What is Sarah's role at Blackmores? ·      What does Sarah enjoy outside of consultancy? ·      What path did Sarah take to become an ISO Consultant? ·      What is the biggest challenge she's faced when implementing ISO Standards? ·      What is Sarah's biggest achievement?   Resources ·      Isologyhub ·      Productivity Ninja   In this episode, we talk about: [00:30] Episode Summary – We introduce Sarah Ball, a Senior Isologist® here at Blackmores, to discuss her journey towards becoming an ISO consultant who specialises in ISO 9001, ISO 45001, ISO 14001 and ISO 27001. [03:45] What is Sarah's role at Blackmores? Sarah is a Senior Isologist® with Blackmores, supporting companies with maintaining systems, undertaking internal audits, and supporting with implementing new systems to gain certification utilising our Isology methodology. Sarah also coordinates the development of content of our online learning platform, the isologyhub. [04:50] What does Sarah enjoy doing outside of consultancy?: Sarah has a keen interest in history, having studied it at school, she like to travel to various locations of historical interest. She also spends a lot of time researching her own family tree, learning as much as she can about the far reaching members of the past. Sarah also likes to go jogging outside, as the gym environment didn't inspire much enjoyment, she instead prefers to be in nature while exercising. She has also participated in long distance running for charity, completing the 10k Race for Life. She's taking on the more daunting muddy 5K version this year, which includes a number of obstacles, so we're wishing her luck! One of the new hobbies she's like to take up this year include mountain climbing, with Mount Snowdon on her to-do list. [06:35] What was Sarah's path towards becoming an ISO Consultant?: Sarah initially started in Customer Services, working as a customer service advisor in a company and then got promoted to manager of a team. At that point, her role became more about understanding why they were getting certain complaints and what could be done to prevent them happening rather than just resolving them. She ended up spending more time with suppliers and other departments to help prevent some of the recurring issues, and along the line it lead onto being asked to implement an ISO 9001 Quality Management System. Which was a tall request considering the fact that at the time, Sarah knew nothing about ISO 9001 outside of it's designation and area of focus. As a result, she spent a lot of time researching it, and had the help of an external consultant to Implement the Management System. This was necessary, as knowing how to apply it to a business was something that she needed support with. 2 years later, the company asked Sarah to implement an ISO 45001 Health & Safety management system and an ISO 14001 environmental management system. These two she implemented herself after getting a feel for it during the initial quality management system implementation. For the next 10 years, Sarah worked in other companies, assisting with their integrated management systems. Along the way, she also picked up on ISO 27001 Information Security, before landing in Blackmores in 2020. [09:10] A path people fall onto – Most people don't actively plan to get into ISO consultancy, it's usually a result of being tasked with managing or implementing a management system while working in another role.  [10:10] What is Sarah's favourite aspect of being a Consultant? – Sarah enjoys the variety, not just in the work and tasks but in the companies and industries that she gets to work with. Each have their own way of working, unique approaches and knowledge nuggets in the form of ways of working that can be cherry picked and applied elsewhere. She also likes to see how a management system develops and evolves overtime and how it can become part of a company's success, driving continual improvement. Sarah enjoys working with people that can see the real benefits of ISO management systems, rather than just focusing on the certificate on the wall. [13:40] Making a Management System your own – Sarah is a big proponent of making a Management system your own, giving it an identity so that it can be fully integrated into the way a business works. Businesses do it all the time, usually by naming large projects that everyone can reference by a common shorthand. A Management System can work in the same way, making it a part of the day-to-day running of the business. She's also a fan of not worrying about the terminology in Standards. Many of the terms used are meant to be general, this was due to the way international audiences referred to certain aspects of management, it wouldn't always translate correctly. So many Standards have some admittedly awkward terminology that can be applied to any business, and you by no means have to use their wording, as long as you can explain what relates to what in an audit then you're free to name things as appropriate to you.   [16:55] What Standards does Sarah specilaise in and why? Starting with: ·      ISO 9001 Quality: This is the main standard that Sarah starting working with, and is one that touches on a lot of areas within other Standards. It's a great base to build off of, and is the starting point for many venturing into the world of ISO. ·      ISO 14001 Environmental: Sarah got experience with this Standard at her first company, it's also commonly implemented alongside ISO 9001.   ·      ISO 45001 Health & Safety: Another one of the first Standards Sarah implemented, it's also a common one to see in integrated management systems.   ·      ISO 27001 Information Security: Sarah got to grips with this Standard through years of working with other companies. Sarah's favourite Standard is ISO 9001, not only because it was her first experience with implementing ISO Standards, but because it create a blueprint for success. ISO Standards are setting the minimum requirement, not the maximum, they are designed get you started so you can make continual improvements. It also acts as a foundation to build onto, you can pick aspects of other Standards to integrate into your existing system. You don't necessarily have to certify to those additional Standards, but nothing is stopping you from strengthening your Management System with the best bits from other ISO's. [21:00] Sarah's favourite clause in ISO 9001: Sarah personally favors Clause 10 – non-conformity and corrective action. The reason behind that choice is due to that clauses' importance in driving continual improvement. It's about taking something negative being turned into a positive, which is what Quality Management is at it's core. [22:05] What is the biggest challenge Sarah had faced during a project and how did he overcome it?: Molding the Standard to the business. As a consultant, the biggest challenge is understanding how to make the requirements of a Standard fit the business, and not the other way round. It's all about trying to align the ISO Standard requirements to their values and mission, and then getting people on board with understanding the true benefits of management system implementation. At Blackmores, we ensure that each management system is unique to each business. We don't operate with a copy paste model. This is another reason why Sarah encourages naming your management system, by branding it you encourage engagement. Sarah highlights the fact that we run a lot of workshops in the initial part of a project, conducting a Gap Analysis, SWOT and PESTLE ect, this helps our consultants to really get a feel for how a business ticks. From that, we can help steer the delivery of the Management System to the wider business, by building it into their existing tools, such as an intranet. [25:45] Leading by example: We revamped our own ISO 9001 Management System a few years ago, with both Rachel Churchman and Sarah Ball leading the refresh. We gave it a name, H20 (How 2 Operate) and integrated it with our Microsoft Teams channels as we'd all swapped to mostly remote work following the COVID pandemic in 2020. As Sarah points out, there are many different ways to display and deliver your management system, including: ·      Microsoft Teams ·      Intranet ·      Google / Google Drive ·      SharePoint ·      CRM's such as Monday.com The key is building it into the day-to-day tools everyone uses. Make the Management System part of your processes, so adhering and maintaining it becomes part of everyone's way of working. [28:55] What is Sarah's proudest achievement? Obtaining her degree through the Open University while still working full time. It took Sarah 8 years of hard work to obtain her honours degree in History, which was one not required by her work or career development. It was simply something she wanted to do to prove to herself that she could achieve it. Many other members of Blackmores can attest to Sarah's level of determination, and organisation, as she shares many tips and techniques learned from her years of study and work. This includes: The Productivity Ninja – Learned from Graham Allcott's book, which seeks to help reduce procrastination, and tackle tasks with efficiency. The Second Brain – A tool to help keep track of ideas / tasks that aren't an immediate priority. These tools are now used by a number of the team, and we have no doubt Sarah will be schooling us on more techniques in future. If you'd like any assistance with implementing ISO standards, get in touch with us, we'd be happy to help! We'd love to hear your views and comments about the ISO Show, here's how: ●     Share the ISO Show on Twitter or Linkedin ●     Leave an honest review on iTunes or Soundcloud. Your ratings and reviews really help and we read each one. Subscribe to keep up-to-date with our latest episodes: Stitcher | Spotify | YouTube |iTunes | Soundcloud | Mailing List

AI remains a hot topic, with many organisations exploring how to integrate its various technologies into their core operations. However, the use of AI presents societal, technical, and legal challenges. In this talk, we will explore how the UK's regulatory approach compares to the EU's AI Act, which will apply from August 2026. Speakers will examine key differences, discuss the practical implications for businesses, and offer insights into ensuring compliance. Join us to gain a deeper understanding of navigating AI regulations and building responsible AI strategies.Speakers:Adam Leon Smith is an expert in AI regulation and technical standards and works on research and strategy projects in that area. He is Chair of the AIQI Consortium, a global initiative to promote the use of the quality infrastructure for responsible AI, and Deputy Chair of the UK's national AI standards committee. He has led four AI standardisation projects in ISO/IEC SC 42 as an Editor and two as a Convenor of SC 42 JWG 2 (Testing of AI systems). He is also very active CEN/CENELEC JTC 21, where he is Project Leader for two projects in response to the AI Act – the Quality Management System for EU AI Act Regulatory Purposes, and AI System Logging. He is also Chair of BCS Fellows Technical Advisory group.Before involvement in quality infrastructure, Adam spent 20 years in senior technology roles, delivering verification and validation solutions for highly complex or high-risk industry challenges. In 2024, the University of Bath awarded Adam an honorary doctorate in recognition of his work and its impact on the profession.David Doyle is known across Europe as a leading expert on EU financial services regulation and long-standing speaker at the Financial Services Club. A former diplomat with over 20 years of service on mainland Europe at bilateral and multilateral level, he now acts as an EU Policy Advisor between Brussels and London, specialising in regulatory developments in banking, fund management and insurance.He is a member of the Executive Board of the joint MEP-EU industry advocacy body, The Kangaroo Group at the European Parliament, holds a seat on the Board of Directors of the Genesis Initiative at Westminster that promotes entrepreneurship and SME policy, as well as being active in the Transatlantic Business Council on Capital Markets and the Conference Board Corporate Governance Council.

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

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

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

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

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

MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf -   MDCG 2024-15 - Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf -   EMA activities on Combination products - Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf -   MDCG 2024-16 Interruption or Discontinuation - For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf -   Joint Paper from 9 Member states - Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf Reduction of Administrative Burdens Centralization of System Management to the EMA Predictable Certification Procedures Enhanced Coordination and Support Impact Assessment and Resource Allocation   -   MDCG 2024-14 Master UDI-DI - Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf Master UDI-DI Assignment Labelling Requirements Vigilance Reporting EUDAMED Registration Implementation Timeline   -   Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf -   Gradual Roll-out of EUDAMED - Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf -   Spain application for in-house devices - For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/ SMARTEYE - Eqms Smarteye: https://eqms-smarteye.com/ EVENTS - Arab Health - January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING -  Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/ ROW -   US - Some healthcare software are not devices - WARNING: https://www.fda.gov/media/184083/download?attachment Administrative support in healthcare settings. Promoting healthy lifestyles without direct links to disease management. Serving as electronic patient records without interpreting or analyzing data. Transferring, storing, converting, or displaying medical data without interpretation. Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.   -   US - PCCP Final guidance - Submit a PCCP with your submission: https://www.fda.gov/media/166704/download • Webinar January 14, 2025 - https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin - South Korea Guidance - Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564 we're talking about new guidance from South Korea's Ministry of Food and Drug Safety, or MFDS. They just released a document to help improve the safety and quality of medical devices." "This guidance focuses on stricter standards for manufacturing and testing medical devices to ensure they are safe and effective for patients." "The MFDS is also emphasizing the importance of proper documentation and reporting, so that any issues can be quickly identified and addressed." The MFDS aims to make medical devices safer through several key measures: Stricter Standards: They are implementing more rigorous manufacturing and testing standards to ensure devices meet high safety and quality benc Enhanced Oversight: Increased oversight and regular inspections of manufacturing processes ensure compliance with safety regulations. Training and Education: Providing training and resources to manufacturers to help them understand and meet the new standards. These steps are designed to ensure that medical devices are safe, effective, and reliable for patients. "In short, this new guidance aims to make medical devices safer and more reliable for everyone." -  Australia - Guidelines for Medical Devices - Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd -  Australia - Submit Custom-made device - Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification -  Malaysia - Advertisement application - Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement PODCAST -  How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/ -  Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/ -  How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/ -  IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/ -  PCCP - The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/ 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 of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 devices?16:20 – Types of PMAs: Traditional, Modular, and Streamlined22:40 – Advantages of PMAs compared to 510(k)s and de novos27:50 – The strategic use of predicates in the PMA process33:00 – Clinical data requirements and misconceptions for PMAs41:10 – Post-market requirements and differences for PMA devices47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals54:30 – Final thoughts on overcoming industry resistance to PMAsStandout Quotes:"Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues"Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues3 Key Takeaways:PMA Isn't the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.Clinical Data Isn't Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.References:Previous Greenlight Guru Webinars by Dr. Mike DruesGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101:PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.Audience Engagement:Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...

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

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

In this episode of the Concrete Logic Podcast, Seth and Dr. Jon Belkowitz delve into the complexities of cement testing, particularly focusing on Type 1L cement and the challenges posed by blended cements. They discuss the importance of establishing a proactive quality management system to ensure the integrity of concrete mixes, emphasizing the need for rigorous testing and quality control measures. The conversation highlights the financial implications of poor quality control and the potential for significant cost savings through proactive measures. Dr. Jon shares insights from his experiences in the industry, advocating for a shift towards more reliable testing practices to enhance the overall quality of concrete production. Takeaways Quality management systems are essential for concrete producers. Type 1L cement is often misunderstood in the industry. Blended cements can lead to unexpected challenges. Proactive testing can prevent costly mistakes. Understanding ASTM standards is crucial for compliance. Quality control can significantly reduce legal liabilities. Investing in quality management can save money in the long run. Communication between teams is vital for quality assurance. Testing frequency should increase with new cement deliveries. The concrete industry must adapt to changing materials and standards. Chapters 00:00 Introduction and Podcast Support 02:22 Donations and Guest Suggestions 08:35 Testing Cement: Ensuring Quality and Specifications 12:09 Understanding the Differences: Type 1L Cement vs. Type 1 Cement 19:58 The Need for a Quality Management System in the Concrete Industry 21:52 Implementing a Vetting Process for Cement: Benefits and Challenges 27:27 Testing Methods and Resources 36:17 The misconception of already doing quality control 41:33 The potential cost savings of proactive quality control 45:31 Avoiding issues by investing in proactive quality control 47:15 The simple steps to improve quality control 49:19 Conclusion and invitation to further discussion***Did you learn something from this episode? Would you like to support the concrete industry's favorite podcast? If so, donate at https://www.concretelogicpodcast.com/support/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ . When YOU donate to the show, you will be listed as a producer of the next episode that is released!***Episode References Guest: Dr. Jon Belkowitz | Intelligent Concrete | Jon@intelligent-concrete.com Guest Website:⁠ https://www.intelligent-concrete.com/Producers: Jodi Tandett Donate & Become a Producer: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.concretelogicpodcast.com/support/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Music: Mike Dunton | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.mikeduntonmusic.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠mikeduntonmusic@gmail.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | Instagram ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@Mike_Dunton⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Host: Seth Tandett, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠seth@concretelogicpodcast.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Host LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/seth-tandett/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Website: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.concretelogicpodcast.com/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/company/concrete-logic-podcast*** Elevate your concrete expertise and join a community of passionate professionals who drive industry innovation at the Concrete Logic Academy! Learn more at https://www.concretelogicacademy.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

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

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 

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

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

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

In this "Best of" episode of the Quality Hub podcast, host Xavier Francis and guests delve into key aspects of ISO auditing. Brandon Lowery emphasizes critical elements like organizational context, quality objectives, and management review in internal audits. Joe Hill and Suzanne Strausser discuss the certification audit's two-stage process, highlighting readiness and detailed operational review. AJ Puylara focuses on evaluating a Quality Management System's effectiveness through continuous improvement and KPIs. Lastly, Joe Hill explains the purpose and process of surveillance audits, to ensure ongoing conformance and effectiveness of the management system. Helpful Resources: Auditing Services:  https://www.thecoresolution.com/iso-auditing-services For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1 Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

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  

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned.  Who is Thomas Lommatzsch?  Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application 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 Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/  AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux  EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320  EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320  French competent authority ANSM: https://ansm.sante.fr/  JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf  MDCG 2022-13 Designation, re-assessment and notification of conformity assessment   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

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers.  Who is Heena Thakkar?  Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.   Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.      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:  Heena Thakkar Linkedin Profile:   https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_appAlceon Medtech Consulting Website:   https://alceonconsulting.com List of standards helpful for cleaning validation of reusable instruments   ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98   USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download)  ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html)  ISO 15883-1:2006: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html)  ISO 15883-5:2021: Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html)  ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html)  ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html)  There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at contact@alceonconsulting.com for additional information or service inquiry. Thank you!   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

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.  Who is Amandine Broussier ? Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD).  Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.      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  Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/  IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html  IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html  IEC 62366-2: https://www.iso.org/fr/standard/69126.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

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions.  Who is Vincent Cafiso ?  Named as one of MD+DI's 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems.     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:  Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/  CREO Consulting Website: https://creoconsulting.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

Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let's find that out with Keith Smith from Vonco  Who is Keith Smith?  Keith Smith is the President and CEO of Vonco Products. Keith has a passion for cultivating infectious energy, innovation, and creation. He generously contributes time and resources to entrepreneurial, education, athletic, and health endeavors. Prior to acquiring Vonco in December of 2012, he served as a General Manager of Carbonless Rolls and Security Papers for Appleton Papers, the largest division of a $1BN paper company. Keith holds a bachelor's degree in industrial engineering as well as an MBA from Northern Illinois University and Lean and Six Sigma certifications from the University of Michigan.      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  Keith Smith Linkedin Profile: https://www.linkedin.com/in/keith-smith-725508b/   Keith Smith Website: https://keithsmith.io/   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

Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues.   Michael will also talk about Zuper which is a FSM software (Field Service Management) and can help you save time and collect the write information. So don't hesitate to check his website.  Who is Michael Israel?  Michael Israel is Vice President of Community and a member of the executive leadership team at Zuper. Michael has worked in customer and field service for more than 40 years. He spent 20 years in his early career managing both domestic and international field service operations, including 12 years with IBM's Field Engineering organization. Over the past three decades, he has held management and executive roles with major providers of CRM and Field Service software applications, including tenures with IFS, Oracle, and SAP.    His broad experience includes marketing, selling, supporting, and implementing CRM and Field Service software applications. Michael also served as a Field Service analyst for Aberdeen Group, the Technology Services Industry Association (TSIA), Jolt Consulting, and the Service Council.     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 Michael Israel Linkedin Profile: https://www.linkedin.com/in/michaelisrael1/  Zuper Website: https://zuper.co  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

The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities.   Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community.  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/  Erik Blog: https://medicaldeviceslegal.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

If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant.  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 Profile: https://www.linkedin.com/in/adam-isaacs-rae/  ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html  ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html  ISO 11737 – Bioburden: https://www.iso.org/standard/66451.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

Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field.  Who is Cesare Magri?  Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.    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 Post High Quality Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-clinicalinvestigation-activity-7173590917466042368-cFdG/  Linkedin Post User Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-survey-activity-7175785619837595648-aRxY  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

The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified.  Who is Steve Curran?  Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market.  He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics.     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:  Steve's LinkedIn: https://www.linkedin.com/in/stephencurran/  Blog on PMS: https://www.trinzo.com/medical-device-pms  PMS Training: https://www.meddevsolutions.co.uk/course/pms-training  Trinzo Website: www.trinzo.com  Trinzo LinkedIn: https://www.linkedin.com/company/trinzo   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

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?  Naveen Agarwal from Exceed will answer this question. So don't miss this episode to know more about QMSR.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time 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:  Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/  Learn more about Let's Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about  Webinar recording - Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr   Risk management training on ACHIEVE:  https://www.achievexl.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