Podcasts about medical device regulation

Der TÜV SÜD hat eine neue Benannte Stelle in Dänemark aufgebaut und bereits erste Zertifkate vergeben. Der Arzt und Global Director des Clinical Centers of Excellence, Dr. Nitsche, verrät im Gespräch mit Christian Johner, was die Motivation für diesen Schritt war, an welche Kundengruppe sich die neue Benannte Stelle besonders wendet und welche Vorteile er für diese Gruppe sieht. Christian Johner nutzt die Gelegenheit, um von Dr. Nitsche zu erfahren, was die üblichen Fallstricke bei der klinischen Bewertung sind, die Medizinproduktehersteller vermeiden sollten.

In this interview, we discuss the potential of AI in increasing healthcare system efficiency, how medical devices are making procedures less invasive and what those working in the field of medical devices can do to help regulation catch up with innovation.

Artificial Intelligence holds the potential to transform much of our lives and healthcare professions are embracing it for everything from cost savings to diagnostics. But who is to blame when AI assisted healthcare goes wrong? How is the law developing to balance the benefits and risks? In this episode, Pam and Rich are joined by health policy expert Michelle Mello and Neel Guha, a Stanford JD/PhD candidate in computer science, for a discussion on the transformative role of AI in healthcare. They examine AI's potential to enhance diagnostics and streamline workflows while addressing the ethical, legal, and safety challenges this new technology can bring. The conversation highlights the urgency of adapting regulatory frameworks, the complexities of liability among hospitals, developers, and practitioners, and the need for rigorous testing to ensure patient safety as AI integration in healthcare advances.Connect:Episode Transcripts >>> Stanford Legal Podcast WebsiteStanford Legal Podcast >>> LinkedIn PageRich Ford >>>  Twitter/XPam Karlan >>> Stanford Law School PageStanford Law School >>> Twitter/XStanford Lawyer Magazine >>> Twitter/XLinks:Michelle Mello >>> Stanford Law page(00:00:00) Chapter 1: Understanding AI in MedicineThe episode begins with a broad introduction to AI's applications in medicine. Neel Guha explains generative AI systems and their rapid advancement, including practical applications like chatbots, imaging, and decision-making tools. Michelle Mello highlights AI's widespread integration, from diagnostic tools like radiological imaging and predictive algorithms to administrative uses that aim to reduce physician burnout.(00:07:04) Chapter 2: The Benefits and Risks of AI in HealthcareThe group explores the advantages of AI in medicine, such as enhanced diagnostic precision, reduced administrative burdens, and improved patient outcomes. Michelle Mello identifies potential risks, like automation bias, where reliance on AI might lead to unchecked errors, highlighting the tension between time-saving tools and maintaining human oversight.(00:08:22) Chapter 3: Legal Challenges and Liability in AI-Driven MedicineThe conversation turns to the legal implications of AI in healthcare. Neel Guha outlines scenarios where AI contributes to patient harm, discussing negligence claims, product liability, and the complexity of determining accountability. Michelle Mello and the hosts analyze how liability standards might evolve, comparing AI's systematic errors to human fallibility and addressing the interplay of human-AI collaboration in preventing mistakes.(00:14:47) Chapter 4: The Challenges of AI and Transparency in Decision-MakingThe group explores parallels between medical and anti-discrimination fields in understanding machine learning's opaque decision-making. Neel Guha delves into the evolution of AI systems from rule-based programming to complex machine learning, emphasizing challenges in identifying points of failure across stakeholders like hospitals, physicians, and developers.(00:17:35) Chapter 5: Regulation and Liability of AI in HealthcareMichelle Mello discusses the regulatory framework for AI as a medical device, comparing outdated 1976-era regulations to modern challenges. The conversation shifts to gaps in tort liability and the risks of developers limiting their liability through contracts. Proposals for redistributing liability to incentivize better private governance are examined alongside the need for robust AI quality assurance akin to crash tests or clinical trials.(00:23:13) Chapter 6: The Road Ahead: Balancing Innovation and SafetyThe speakers analyze the distinct challenges of regulating AI across diverse healthcare environments. Neel Guha and Michelle Mello discuss adapting evaluation practices to align with AI's real-world complexities. Optimism prevails as Michelle highlights AI's potential to address critical issues like diagnostic delays, advocating for guardrails to ensure safety without stifling innovation. The episode concludes with reflections on Stanford's interdisciplinary approach to these pressing issues.

In der 244. Folge von „bto – beyond the obvious – der Ökonomie-Podcast mit Dr. Daniel Stelter“ geht es um den erheblichen Schaden, der durch die Regulierungswut des Staates bei Wohlstand und Wohlergehen angerichtet wird. Am konkreten Beispiel der Medizinbranche wird deutlich, dass die Bürokratie nicht nur Kosten verursacht und Prozesse verlangsamt, sondern Innovation verhindert und Heilungschancen sowie Lebensqualität von unzähligen Menschen in der EU verringert – mit zum Teil fatalen Folgen bis zum Tod. Hintergrund dieser bestürzenden Entwicklung ist die sogenannte „Medical Device Regulation“, kurz MDR, die 2021 in Kraft getreten ist. Statt Patienten besser zu schützen, dürfte das Gegenteil erreicht werden und ohne rasche Reform droht Europa in einer weiteren wichtigen Industrie den Anschluss zu verlieren.Wie die EU-Regulierung Innovation verhindert und der hiesigen Wirtschaft schadet, erläutert Nino Weiland, Gesellschafter und Operations Manager bei NGMedical im Gespräch mit Daniel Stelter. Die NGMedical GmbH ist auf Implantate für die Wirbelsäulenchirurgie spezialisiert. HörerserviceDie zitierte Studie des ifo Instituts zum Standort Deutschland finden Sie hier. Den Link zur DIHK-Umfrage finden Sie hier. Neue Analysen, Kommentare und Einschätzungen zur Wirtschafts- und Finanzlage finden Sie unter www.think-bto.com. Sie erreichen die Redaktion unter podcast@think-bto.com. Wir freuen uns über Ihre Meinungen, Anregungen und Kritik.ShownotesHandelsblatt – Ein exklusives Angebot für alle „bto – beyond the obvious – featured by Handelsblatt”-Hörer*innen: Testen Sie Handelsblatt Premium 4 Wochen lang für 1 Euro und bleiben Sie zur aktuellen Wirtschafts- und Finanzlage informiert. Mehr erfahren Sie unter: https://handelsblatt.com/mehrperspektiven Werbepartner – Informationen zu den Angeboten unserer aktuellen Werbepartner finden Sie hier. Hosted on Acast. See acast.com/privacy for more information.

In this episode, we're counting down to a shift in the medical device industry: the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Our expert, Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance, discusses the main challenges for manufacturers, explains the key differences between MDR and MDD, reviews the MDR timeline, and walks through the next steps for the MDR application process. Tune in to gain valuable insights into navigating the evolving landscape of medical device regulation.Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.

In episode number 36 of the Podcast "International Pharma Talks by ELS Solutions" our host, Dr, Diogo Sousa Martins, PhD, MBA, will focus on "Challenges of the new Medical Device Regulation in Europe".

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Masimo is planning to spin off its consumer unit two years after acquiring Sound United for its audio brands. In other news, an EU court adviser has sided with Illumina in a dispute that triggered a fine for Grail, Vyaire Medical has recalled resuscitators linked to two deaths, and Medtronic claims a win in a patent dispute with Axonics. The FDA's looming rule on laboratory-developed tests has experts warning that patients may lose access to critical tests. Despite the Medical Device Regulation going into effect in the EU, key infrastructure is not fully operational, posing challenges for small and medium-sized medtech companies. Advocate, a health system, has sold its senior home care business to private equity firm Waud Capital Partners. Change, a technology firm, announced that its largest claims clearinghouses are coming back online, with over $14 billion in claims ready for processing. Experts are warning that patients may lose access to critical diagnostics as the laboratory-developed test rule looms, leading to increased FDA oversight of such tests. Hospital groups have questioned HHS about data breach reporting following the Change cyberattack.Regeneron's bispecific antibody odronextamab received two complete response letters from the FDA due to issues with its confirmatory trials. Meanwhile, Novo Nordisk acquired mid-stage biotech company Cardior Pharmaceuticals, expanding its presence in heart disease treatment. AbbVie also acquired Landos Biopharma, adding an oral NLRx1 agonist for inflammatory and autoimmune diseases to its portfolio. The FDA approval of Novo's weight loss drug, Wegovy, for cardiovascular disease will likely increase access for Medicare patients. In the biopharmaceutical industry, there is a focus on innovation in recombinant antibodies and the exploration of new indications beyond diabetes and obesity for GLP-1 agonists.Marketers are optimistic about the potential of generative AI to boost the creator economy, with three-quarters planning to increase investment in generative AI content. Mountain Dew is targeting gamers and outdoor enthusiasts with rewards programs, while PepsiCo has created a Flamin' Hot brand to highlight their fast-growing chip flavor. The latest TikTok ban attempt could benefit Meta and impact advertisers, and brands are pivoting to video successfully this time around. Levi's new campaign positions the brand as the "unofficial uniform for progress" by passing the pen to consumers. Overall, automation is seen as a key tool for marketers to accelerate digital ad production and distribution.

Die EU bereitet eine neue Produkthaftungsrichtlinie vor, die insbesondere Medizinproduktehersteller betrifft, explizit auch solche, deren Produkte Verfahren der künstlichen Intelligenz (KI) verwenden. Prof. Johner klärt im Gespräch mit dem auf Medizinprodukte und Produkthaftung spezialisierten Rechtsanwalt Boris Handorn wichtige Fragen.

In this episode, Host Simon Hodgkins is joined by Olga van Grol-Lawlor, Senior Global Regulatory Intelligence and Advocacy Manager at Boston Scientific. The medical device industry stands at the intersection of healthcare and technology, continuously pushing the boundaries of what's possible. However, with innovation comes the need for regulation, a topic that often finds itself at the center of many industry discussions. Olga and Simon discuss the current and future requirements in the medical devices regulation area, digital health, and the wider implications for European and Global healthcare.

Klaus Müller erläutert im Gespräch mit Christian Johner die verschiedenen Möglichkeiten, Software wiederzuverwenden. Er unterscheidet dabei - Komponenten, - Frameworks und - Backend-Services (Software as a Service). Die Funktionalitäten, die sich damit abbilden lassen, lassen sich unterscheiden in - indikationsspezifische Funktionen, - Funktionen, die spezifisch für das Gesundheitswesen sind, wie Anbindung an die Telematik-Infrastruktur oder Anonymisierung von Daten und - Querschnittfunktionalitäten, die jedes Software anbietet, wie Datenspeicherung und Autorisierung. Klaus Müller gibt Tipps, auf was Medizinproduktehersteller achten sollten, die ihre Entwicklung beschleunigen, indem sie Software wiederverwenden.

Bei einer Konferenz zur KI im medizinischen Bereich wurde die Aussage getätigt, dass eine Inverkehrbringung vorläge, wenn Forschende ihre Algorithmen bei Github einstellen, falls diese Algorithmen für die Diagnose, Therapie und Überwachung von Krankheiten genutzt werden können. Das verursachte große Verunsicherung in der "Research Community". Das haben wir als Anlass genommen, um mit dem Rechtsanwalt Boris Handorn zentrale Fragen zu klären.

A systemic approach to care for non-communicable diseases like hypertension and diabetes is Africa is in its early stages, with the biggest challenge for patients being the price of medications, says Anne Stake, Chief Strategy and Product Officer at Medtronic Labs.  Medtronic Labs is a nonprofit organization that works with governments and local communities in across Africa to create local ecosystems for the management of hypertension and diabetes. In this episode, Anne Stake explains: how does Medtronic Labs work, why are they present in Africa, how to run successful non-communicable diseases programs in Africa, why regulation isn't as loose in less developed markets than the West might think, ...and more! This is a rerun of an episode first published in July 2022. www.facesofdigitalhealth.com Excerpt and full episode with Anne Stake: https://www.facesofdigitalhealth.com/blog/medtronic-labs-africa?rq=medtronic Herve Mwamba - South Africa & Africa More Broady: What's The State of Medical Device Regulation? : https://www.facesofdigitalhealth.com/blog/medical-device-regulation-mdr-africa?rq=herve%20 Newsletter: https://fodh.substack.com/ Leave a rating or a review: https://lovethepodcast.com/facesofdigitalhealth

Martin Schoedel war bei mehreren Konzernen in leitender Position verantwortlich für das Regulatory und Quality Management. Er beschreibt, welche Themen Regulatory Affairs und Quality Manager beschäftigt haben und künftig beschäftigen sollen. Dabei gibt er auch Tipps, welche Fähigkeiten und Kenntnisse diese Personen sich aneignen sollten. Martin Schoedel skizziert seine Vision für diese Bereiche und damit ein sehr attraktives Zukunftsbild: Regulatory & Quality Management als strategische Partner im Unternehmen.

BSI's Graeme Tunbridge, Qserve's Gert Bos and TUV SUD's Andreas Stange talk with Medtech Insight's Amanda Maxwell about how the recent amending regulation to the EU's Medical Device Regulation has changed the EU medtech regulatory landscape.

Mon, 10 Jul 2023 14:56:57 +0000 https://johner-institut.podigee.io/76-umfrage-ungerechtfertigte-anforderngen 033de7a1e9081d1cf015d7d295dddfa9 Das große Fingerpointing Für Medizinproduktehersteller wird es immer schwieriger, ihre Produkte in den Verkehr zu bringen. Sie verlieren dramatisch an Wettbewerbsfähigkeit. Das zeigt sich auch am implodierenden Marktanteil deutscher Hersteller in Deutschland. Doch wer ist schuld? Die Hersteller sagen, es seien die MDR und die ungerechtfertigten Forderungen durch die Benannten Stellen. Die Benannten Stellen schieben die Schuld auf die ZLG und die MDCG-Dokumente. Und deren Autoren sind nicht auffindbar. Um etwas Licht in die Sache zu bringen, hat das Johner Institut eine Umfrage gestartet. Sie hat das Ziel herauszufinden, wo Anforderungen gestellt werden, die über die der MDR bzw. IVDR hinausgehen. Was dabei herausgekommen ist, berichtet der Regulatory Scientist des Johner Instituts, Sven Wittorf, in diesem Podcast mit Professor Johner. Wenden Sie sich bei weiteren Fragen an Sven Wittorf Senden Sie eine E-Mail Prof. Dr. Christian Johner (via Kontaktformular) 76 full Das große Fingerpointing no Zulassung Medizinprodukte,Benannte Stellen,MDCG,Medizintechnik,Medical Device Regulation,EU-Kommission Sven Wittorf, Prof. Dr. Christian Johner

This special episode of the Market Pathways podcast features a panel discussion from our recent Medtech Strategist Dublin Innovation Summit. This session brings together an experienced group of CEOs and investors discussing how the new Medical Device Regulation is impacting day-to-day decision-making in running their companies and deciding which start-ups they will invest in given the ever-changing regulatory climate in Europe.

Die IEC 60601-1 fordert die funktionale Sicherheit explizit, die EU-Medizinprodukteverordnung MDR zumindest indirekt. Mario Klessascheck berät die Kunden des Johner Instituts beim Entwurf funktional sicherer Medizinprodukte. Im Podcast berichtet er, was die regulatorischen Anforderungen an die funktionale Sicherheit sind und wie Hersteller diese erreichen. Auf das Zusammenspiel mit der Norm IEC 61508 geht er dabei ebenso ein wie auf das neue "Interpretation Sheet" der IEC. Beachten Sie auch die Webseite zur funktionalen Sicherheit.

SOUNDS OF SCIENCE - EPISODE 15 On today's episode, we focus on the EU's Medical Device Regulation (MDR) which came into full effect on 26 May 2021 and followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year. The idea of both regulations is to balance the regulatory review and approval processes of medical devices and IVDs across all EU Member States, essentially harmonizing the European market for medical devices. However, the Medical Device Regulation is causing some problems, and stakeholders and politicians at both the national and EU levels are warning that the MDR is leading to potential medical device shortages, and even medical devices disappearing from the EU market as a whole. In short, the main problem is that under the MDR, all medical devices produced in Europe must be re-certified. Re-certification needs to be done by a notified body, which is a national organisation designated by an EU country to assess the conformity of devices placed on the market. The main reason for the shortages is the capacity of these notified bodies to recertify. There are currently only 36 notified bodies with 23,000 certificates that need to transfer very much at the same time. Also, most manufacturers are not prepared for the new and sometimes costly rules of the MDR. In light of all this, and primarily to prevent the imminent risk of shortages, the European Commission decided to amend the medical device and in vitro diagnostic regulations. To help us breakdown the recent changes and what it means for EU medical device companies, we're joined by three experts in the medical devices space: Jörg Plessl, Head of Global Regulatory Affairs, Norgine Megan Doyle, Director, Global Regulatory and R&D Policy, Amgen Axel Korth, Sr. Legal and Regulatory Affairs Advisor, EUCOPE  --------------------------------------------------------------------------------- If you're a medical device company looking to add your voice to the ongoing debate and need help navigating the complex EU medical device market, please reach out to EUCOPE's Leander Vranken (vranken@eucope.org) to learn how to join our MDR/IVDR Focus Group.

Benannte Stelle beginnen damit, Herstellern Probleme zu bereiten, die Excel nutzen, um das Risikomanagement für komplexere Medizinprodukte abzubilden. Christian Rosenzweig, der am Johner Institut auch die Seminare Risikomanagement hält und Hersteller dabei unterstützt, berichtet im Gespräch mit Professor Johner, - ob diese Forderung Benannter Stellen überhaupt gerechtfertigt ist, - wann die Einführung eines Tools fürs Risikomanagement gerechtfertigt ist, - auf was die Hersteller bei der Auswahl eines Tools achten sollten und - welche die Fallstricke sie bei der Einführung eine Werkzeugs vermeiden sollten. Denn mit oder ohne Tool, die Ziele bleiben die gleichen: - Hersteller möchten Ihre Produkte schnell und planbar und ohne unnötige Aufwände in den Markt bekommen. - Die Medizinprodukte müssen sicher, d.h. die Risiken zuverlässig erkannt und beherrscht sein.

Spätestens seit in Krafttreten der MDR müssen die Hersteller die IT-Sicherheit ihrer Medizinprodukte nachweisen. Das Johner Institut ging davon aus, dass die Benannten Stellen diese Anforderungen Stück für Stück erfüllt sehen wissen. Doch die Erfahrungen in vielen Beratungsprojekten zeigt, dass diese Annahme nicht zutreffend ist. Christian Rosenzweig, der am Johner Institut auch die Seminare zur IT-Sicherheit hält und Hersteller dabei unterstützt, berichtet im Gespräch mit Professor Johner, welche Schwerpunkte die Benannte Stellen haben, welche Kritikpunkte sie äußern und wie es Herstellern gelingen kann, die "Zulassungen" dennoch schnell und sicher zu erhalten.

Here is your Regulatory Update for the month of February 2023. Check all the links below – EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en – Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24 – General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT – Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1 – EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en – EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en   – EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf   – Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en   – Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24 – UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices   – UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices   – Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf – Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html - EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 - EU IVDR : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35  – Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf   – Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop  

What happens when two regulatory consultants sit down for a chat about MDR? A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry. Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

What happens when two regulatory consultants sit down for a chat about MDR? A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry. Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

EU MDR extension Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf Provisional Agenda 9th Meeting – Implementation of the Medical Device Regulation (MDR) https://data.consilium.europa.eu/doc/document/ST-15453-2022-INIT/en/pdf Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period extension proposal by the European Commission. https://video.consilium.europa.eu/event/en/26353 Erik Vollebregt Article: https://medicaldeviceslegal.com/2023/01/01/mdr-and-ivdr-outlook-for-2023/ Implementing rolling plan Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Latest update: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf Borderline manual Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – Version2 – December 2022 https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en Team NB AI act for Notified Bodies – Team-NB Position Paper – The designation of notified bodies under the upcoming Artificial Intelligence Act https://www.team-nb.org/wp-content/uploads/members/M2022/Team-NB PositionPaper-AI Designation-V1-20221216.pdf Notified Bodies appointed QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320456&version_no=1 ICIM S.P.A., 36th Notified Body designated under MDR (EU) 2017/745 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320256&version_no=12 11:31 UK Approved bodies UK Approved bodies. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices Training to attend and Books to read Green Belt 24th Edition : https://school.easymedicaldevice.com/course/gb24/ EUDAMED Simplified 28th February 2023: https://eudamed.com/index.php/eudamed-training/ PRRC Training 28 Feb 2023: https://boumansconsulting.com/prrc-academy-cat/2023-02-28-03-07-in-house-manufacturer-prrc-starter-training/ Erik Vollebregt Book – easymedicaldevice10 https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ MDCG 2022-17 MDCG position paper on ‘hybrid audits' – December 2022 https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en MDCG 2022-19 and 20 Performance study application/notification documents under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en Substantial modification of performance study under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-20-substantial-modification-performance-study-under-regulation-eu-2017746-december-2022-2022-12-14_en MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en Switzerland Annex XVI products Frequently Asked Questions on medical devices – FAQ MD: Update of the section “Products without medical purpose” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html US Product Codes Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies Augmented Reality and Virtual Reality in Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices SFDA Classification Guidelines for classification of medical devices and supplies https://www.sfda.gov.sa/sites/default/files/2022-12/MDS–G008.pdf PODCAST nostalgia Team-PRRC panel discussion https://podcast.easymedicaldevice.com/210-2/ Is EU MDR extended? https://podcast.easymedicaldevice.com/211-2/ Grow your LinkedIn Profile: https://podcast.easymedicaldevice.com/212-2/

Monir El Azzouzi created the Easy Medical Device ecosystem, that includes blogs, podcasts, YouTube videos and regular updates in LinkedIn. His mission is to make the process of bringing Compliant Medical Device to the Market easier. He has a deep understanding of the Medical Device Regulations at European Union. Easy Medical Device: https://easymedicaldevice.com/home/

Connected and intelligent medical devices are becoming an increasingly important part of our healthcare systems. In this episode, Matthew speaks to Andrew Mkwashi from UCL - one of the co-authors of a new White Paper on the future of medical device regulation and standards. The White Paper is the result of a research partnership between BSI, UCL and PETRAS - the UK National Centre of Excellence for the Internet of Things.He also speaks to Rob Turpin of BSI about how the findings of the White Paper will be used to make a difference to the development of medical device standards.And Emma Glass joins him to discuss BSI's ambition to develop and expand research partnerships between BSI, researchers and universities in healthcare technologies. Find out moremedicaldeviceswhitepaperbsigroup.com/medicaldevicesGet in touch@standardsshow@thestandardsshow education@bsigroup.com

It's September, it's time for school and a new season of Faces of digital health podcast episodes. Faces of digital health strives to bring you an insight into digital health development across the world. We're going to start this season in Africa. In this episode, South African entrepreneur, regulatory, and quality assurance consultant Herve Mwamba discusses the state of medical device regulation in South Africa and Africa more broadly, his observations about the consequences and problems related to the European Medical Device Regulation, his observation regarding innovation in Africa.  This is the first of a few episodes where speakers talked about the African market, so do make sure to subscribe to the show to be notified about other episodes automatically. In the next episode you'll hear about chronic disease management in Kenya and Ghana, provided by Medtronic Labs, and after that, a discussion about the prevention of sexually transmitted diseases and how that can be improved with the rise of at-home testing. BTW - did you read our newsletter yet? We finally have one! It only comes out monthly, filled with information about insights in the last month. Do check it out here: Newsletter: https://fodh.substack.com/ www.facesofdigitalhealth.com www.lovethepodcast.com/facesofdigitalhealth 

The Turkish Pharmaceuticals and Medical Devices Authority recently published the Guidance on Good Distribution Practice for Medicinal Products for Human Use and the Guidance on Risk-Based Good Clinical Practice Audits. In addition, it has amended the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Moreover, the Ministry of Health recently amended the Regulation on the Cascading of Health Service Providers.

Jetzt kostenloses Strategiegespräch vereinbaren unter https://svenwalla.de/termin Im letzten Interview ging es um die Wawi Box Pro Materialwirtschaft, sinnvolles Bestellen und weniger Wegwerfen, weniger Lagerbestand. Heute erklärt Laura Zahn, wie MDR, Medical Device Regulation, auch in Ihrer Praxis zu keinem nervenraubenden Thema mehr wird. Buchen Sie sich jetzt Ihren Termin zum kostenlosen Erstgespräch auf www.svenwalla.de

Post-market surveillance requirements apply to all products under the Medical Device Regulation. But it is not just about compliance. Companies would do well to evaluate the additional benefits added PMS efforts can offer them, leading devices expert Bassil Akra explained during a recent interview with Medtech Insight. And he explained how small companies can be equally competent at PMS as large companies.

The Turkish Pharmaceuticals and Medical Devices Authority recently announced that the Medical Device Clinical Trials Regulation is open for public consultation. The Draft Regulation introduces certain amendments to ensure the medical device clinical trial process's compliance with the Medical Device Regulation.

Richard Houlihan is the founder of EirMed, a company specialising in EUDAMED training & support, he was part of the original team at the European Commission who managed, designed, and led the development of EUDAMED. Richard has considerable knowledge when it comes to EUDAMED, the current European database on medical devices. He started his career in IT working as a programmer going into project management and had spent over 8 years working within the European Commission in Brussels, Belgium helping build the EUDAMED system. In this episode he discusses why the EUDAMED system was created, the issues the medical device industry currently faces, the challenges the new Medical Device Regulation and Brexit has brought into the EU and why companies are not currently allocating resources to learning about this new system. Get in touch with Richard Houlihan - https://www.linkedin.com/in/richard-houlihan/ or https://eudamed.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast

Happy New Year 2022. All my best wishes for this year. For all the updates. check the links below. Links:Green Belt Edition 15 – January 2022: http://school.easymedicaldevice.com/course/gb15/ Progressive Roll-out of the In Vitro Diagnostic Medical Devices Regulation: https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965 02 Expert Panel Review: Screen donor samples for HEV RNA in plasma samples https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf 03 Expert Panel Review: Detection of West Nile Virus (WNV) RNA in plasma and serum specimens. https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000003-view_en.pdf 04 Expert Panel Review: Test for direct detection of Babesia DNA and RNA in whole blood samples: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000004-view_en.pdf 05 Expert Panel Review: Qualitative in-vitro nucleic acid screening test for the direct detection of ZIKA virus RNA in human plasma [RECOMMENDATION PROVIDED]: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000005-view_en.pdf MDCG 2022 meetings: https://ec.europa.eu/health/sites/default/files/md_dialogue/docs/md_events_2022_en.pdf Team NB Position paper on MDR/IVDR Implementation: https://www.team-nb.org/wp-content/uploads/2021/12/Team-NB-PositionPaper-on-MDR_IVDR-Implementation-V2.pdf eIFU: https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj The Fast-Track Process for DiGA: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile Swissmedic Simplifies labeling Obligations: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016d_MB_Pflichten_Wirtschaftsakteure_CH.pdf QUNIQUE translation: https://lnkd.in/ghreiitJ Swiss notification mandate form updated: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/formular-mandat-chrep.html Medsun December 2021: Reporting of problems from 300 hospitals, nursing homes, and home health facilities in the USA. https://www.fda.gov/media/154761/download Medical Device Regulation Overview and update – Eng Abdullah Alghuraibi: http://www.ahwp.info/sites/default/files/Annex18_Saudi%20Arabia%20updates.pdf DoC template: https://www.sfda.gov.sa/sites/default/files/2021-12/MDMA-Annex15v6.docx EU: MDCG 2021-27 Questions and answers on article 13 & 14 of MDR & IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-27_en.pdf Erik Vollebregt Article: https://medicaldeviceslegal.com/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/ EU: MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf TÜV NORD CERT GmbH: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315449&version_no=26 Episode 158: Which devices cannot be Custom-made [Erik Vollebregt]: https://podcast.easymedicaldevice.com/158/ Episode 159: The Step-by-step recipe to get MDR and IVDR certified: https://podcast.easymedicaldevice.com/159/ Episode 160: What happened in 2021: https://podcast.easymedicaldevice.com/160/ Social Media to followMonir 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 post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on biocidal products, the Overseas Drug List, products whose class has changed in accordance with the Medical Device Regulation, international and domestic Good Manufacturing Practices (GMP) certification and inspection processes.

Nadine Langguth beschreibt im Gespräch mit Professor Johner ihre Aufgaben als RA-Managerin. Sie berichtet, mit wem sie zusammenarbeitet, welche Herausforderungen sie zu bewältigen hat und was Sie sich wünschen würde.

The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on the implementation of the Medical Device Regulation and the normalization process following the COVID-19 pandemic.

In this episode... Renaud Anjoran is joined again by Clive Greenwood, an expert in product compliance for a new episode following on from the first episode they recorded about product compliance (which covered the main compliance challenges faced by importers). This time they're looking at the future of compliance standards by examining the new Medical Device Regulation (EU) 2017/745 (MDR) which they believe signposts how future regulations will evolve and will definitely heavily impact you if you're a medical device importer and, soon, for many other product types in all likelihood. So, how much of a change is this regulation and how could it change what you have to go through and provide to get your products certified in future? Let's put it this way, if you're not 100% compliant be afraid as the authorities are going to come for you and now they have teeth!   Show Notes 00:00 - Introduction.  01:54 - Clive introduces himself and what he does.  03:28 - What is the Medical Device Regulation (EU) 2017/745 (MDR) and when did it come into effect?  05:44 - If you import medical devices into the EU and have a CE certificate granted under the old MDD, when do you have to switch and will it be an easy transition?  06:42 - The Scope of the MDR  07:51 - Previously customs found it difficult to check that medical devices were certified, will that still be the case? 12:39 - The MDR requires a LOT more information about your QMS and processes in the technical document pack than just samples passing certification before certification can be achieved. 15:37 - Notified bodies now have to take more action to monitor ongoing production after certification. 16:13 - Who's liable now (post-MDR) if there is any trouble with the products?  20:36 - What happens if it's found that a fake document was submitted or a problem was found? 24:06 - How can companies transition from the old MDD to the new MDR? 30:08 - What if you're planning to bring a medical device to the market soon?  34:43 - Why is the EU MDR beneficial?  36:45 - Wrapping up.    Related content... Read the entire Medical Device Regulation (EU) 2017/745 (MDR) Compliance testing consulting from Sofeast We're Buying Medical Devices From China And Are Worried Our Supplier Isn't Legit | Disputes With Chinese Suppliers Q&A (Volume 8) Do Sofeast's quality inspectors confirm that the products are fully compliant based on certificates provided by the factory? 11 Common Electronic Product Certification And Compliance Requirements Why YOU Need a Product Safety Program Can Sofeast help us with the certification of our new product? What Is Compliance Testing? [Podcast] US Compliance Documents When Importing from China: Q&A With an Expert Product Compliance 101: What Every Importer Must Know [Q&A]   Get in touch with us Connect with us on LinkedIn Send us a tweet @sofeast Prefer Facebook? Check us out on FB Contact us via Sofeast's contact page Subscribe to our YouTube channel   Subscribe to the podcast  There are more episodes to come, so remember to subscribe! You can do so in your favorite podcast apps here and don't forget to give us a 5-star rating, please: Apple Podcasts Spotify Stitcher Google Podcasts TuneIn Deezer iHeartRADIO PlayerFM Listen Notes Podcast Addict

In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property. The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast.

The Medical Device Regulation ("Regulation") was published in Official Gazette No. 31499 on 2 June 2021. The Regulation, which is fully harmonized with the European Union (EU) legislation, aims to enhance the quality of medical devices and provide a more secure use for medical device users and patients. The Regulation is available (in Turkish) here.

Christopher Robertson joined the Boston University law school faculty in 2020 as a tenured professor and an N. Neal Pike Scholar in health and disability law. Prior to that, he served as associate dean for research and innovation and professor of law at the University of Arizona. He is also a principal at Hugo Analytics, a firm that  provides scientific services to litigators. In 2019, Harvard University Press published his book, Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. Chris has also co-edited three books, Nudging Health: Behavioral Economics and Health Law (2016,) Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law (2016), and Innovation and Protection: The Future of Medical Device Regulation (2021). Chris graduated magna cum laude from Harvard Law School and earned a doctorate degree at Washington University in St. Louis. He has taught at Harvard Law School, NYU Law, and the London School of Economics. John Marchica, CEO, Darwin Research GroupJohn Marchica is a veteran health care strategist and CEO of Darwin Research Group, a health care market intelligence firm specializing in health care delivery systems. He’s a two-time health care entrepreneur, and his first company, FaxWatch, was listed twice on the Inc. 500 list of fastest-growing American companies. John is the author of The Accountable Organization and has advised senior management on strategy and organizational change for more than a decade. John did his undergraduate work in economics at Knox College, has an MBA and M.A. in public policy from the University of Chicago, and completed his Ph.D. coursework at The Dartmouth Institute. He is a faculty associate in the W.P. Carey School of Business and the College of Health Solutions at Arizona State University, and is an active member of the American College of Healthcare Executives. About Darwin Research GroupDarwin Research Group Inc. provides advanced market intelligence and in-depth customer insights to health care executives, with a strategic focus on health care delivery systems and the global shift toward value-based care. Darwin’s client list includes forward-thinking biopharmaceutical and medical device companies, as well as health care providers, private equity, and venture capital firms. The company was founded in 2010 as Darwin Advisory Partners, LLC and is headquartered in Scottsdale, Ariz., with a satellite office in Princeton, N.J.

Die MDR startet im Mai 2021 - Christian hat dazu zwei ZM Artikel geschrieben und wir unterhalten uns auch über seinen Podcast.

Die MDR hat die Anforderungen deutlich erhöht, die Hersteller von stofflichen Medizinprodukten berücksichtigen müssen. Das beginnt von der Klassifizierung und endet nicht bei den Nachweisen zur Kinetik dieser Produkte. Maike Andersson erläutert im Gespräch mit Professor Johner, was stoffliche Medizinprodukte sind und wie sich diese von Arzneimitteln abgrenzen. Sie listet die (neuen) Anforderungen an diese Klasse an Medizinprodukten und gibt Tipps, wie Hersteller diese erfüllen kommen. Besonders relevant sind auch die Hinweise, wie Hersteller klinische Prüfungen und die unbeabsichtigte Klassifizierung als Arzneimittel von stofflichen Medizinprodukten vermeiden können.

Die MDR und IVDR fordern jeweils im Artikel 11 die Rolle des EU-Bevollmächtigten. In diesen Podcast erläutert Margarita Rozhdestvenskaya im Gespräch mit Professor Johner, welche Aufgaben sie als EU-Bevollmächtigte übernimmt, welche regulatorischen Anforderungen sie dabei beachten muss, wie sich diese Anforderungen von der MDD zur MDR geändert haben und auf was man achten sollte, wenn man die Rolle des Bevollmächtigten outsourced.

Peter and Patrick discuss the EU's MDR requirements taking affect in the near future, what it means for the translation industry, how it helps to increase global business, and the benefits for the average person trying to understand these medical devices.

In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcast... A lot to cover. The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.

David Nathans joins the podcast to talk about how medical device makers work with each other and with regulators around the world.

The three-year transition period for the new Medical Device Regulation will end on 26 May 2020, and the new In Vitro Diagnostic Regulation will come into force in 2022. These new pieces of legislation bring changes to one of the pillars of the medical technology sector: the CE marking process. In this episode, we speak to Oliver Bisazza about what this process is, how it changes and what the medtech industry has to say about it.

In May 2020, Medical Device Regulation goes into effect. Digital health companies providing software intended for medical use will need to comply with new requirements. According to Jovan Stevović, CEO and Co-Founder of Chino.io, companies are much better prepared for MDR than they were for GDPR. In general, medical devices are products or equipment intended for medical use. These include long-term corrective contact lenses, surgical lasers, defibrillators, hearing aids, diagnostic ultrasound machines, hip-joint implants, prosthetic heart valves. There are three classes of medical devices: Class 1, Class 2a and 2b, and Class 3. The classification depends on the intended use. Medical devices class I have the lowest perceived risk for health, those in Class 3 the highest. MDR also defines software which is designed for medicinal purposes, to be a medical device.   Recap of the show: www.facesofdigitalhealth.com/blog/f062-gdpr-mdr-and-what-you-can-do-about-you-medical-data-jovan-stevovi Chino.io: https://www.chino.io/ Free eBook: How to build MDR certified eHealth applications: https://www.chino.io/a/chino-io-ebook-medical-device-regulation-ehealth-applications 

According to Clearwater cyberIntelligence Institute, one of the key issues in data breaches are user authentication deficiencies. These include password strength requirements, single sign-on controls, and locking accounts after too many failed login attempts are the three primary risks around user authentication - generic password use, physically posting passwords on a workspace, and or unencrypted emailing of credentials over external networks. If the key issue of data security and privacy protection in the past was how to archive data and prevent unauthorized access to archives, the cloud brought a whole new set of challenges. For one thing, security measures required from the personnel are getting increasingly complex. Additionally, while several advances have been made on the technological level of data protection - from different methods of encryption to high hopes stemming from AI and quantum computing, the bad guys are also using these technologies, says Chris Bowen, the Founder of and Chief Privacy & Security Officer of ClearDATA - US based company offering technology and services to assist organizations with their healthcare cloud security needs. We discussed the trends in cybersecurity in healthcare, the future, and what organizations should be mindful of when it comes to healthcare data protection. Enjoy the show, find the transcript on our website www.facesofdigitalhealth.com, and do subscribe to the show if data privacy, security and protection is on your interest. In the next episode, you will hear about GDPR and upcoming Medical Device Regulation from Jovan Stevović, Co-Founder of Chino.io.  Recap:https://www.facesofdigitalhealth.com/blog/f061-why-do-so-many-data-breaches-and-cybsecurity-attacks-happen-in-healthcare-chris-bowen  ClearDATA: https://www.cleardata.com/ Chris Bowen: https://www.linkedin.com/in/cbowen1/

PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to choose the right person. The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode. The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

Changes are in progress, with more to come, in both the US and EU. FDA’s Center for Devices and Radiological Health (CDRH) is undergoing a significant reorganization in terms of both personnel and office responsibilities. In the EU, the new Medical Device Regulation will take effect in less than a year. RAPS invited Allison Komiyama, PhD, RAC, and expert on the US device environment, and John Beasley, RAC, whose primary focus is EU devices, to discuss those changes and their impact on device manufacturers.

https://accadandkoka.com/wp-content/uploads/2018/09/Lenzer-image-e1537398428534.jpg ()Jeanne Lenzer Are doctors patsies for the medical device industry?  Are patients put in harm’s way for lack of tough standards on new device approvals?  We examine the question with Jeanne Lenzer, award-winning investigative journalist and author of https://www.amazon.com/Danger-within-Us-Americas-Unregulated/dp/0316343765 (The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It). GUEST: Jeanne Lenzer’s https://jeannelenzer.com/ (Website) and https://twitter.com/JeanneLenzer1?lang=en (Twitter) LINKS: http://bleedingedgedoc.com/ (The Bleeding Edge) (documentary) WATCH ON YOUTUBE: https://youtu.be/LPQxkcGgYxI (Watch the episode) on our YouTube channel Support this podcast

Interview with Diana M. Zuckerman, PhD, author of Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices, and Joshua Sharfstein, MD, author of Improving Medical Device Regulation: A Work in Progress