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Press Releases ‘Medical Device Law Award 2006’ presented to JMDR Editorial Advisory Board member Rainer Hill 2024 Media Guide now available 2025 Media Guide now available A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe A focus on medical device regulation in the UK after Brexit, a regulatory country overview on Peru, reusable ophthalmic devices, views on biological evaluation from the Italian AFI Regulatory Affairs Working Group, the regulation of SaMD in the USA, and much more now available in the November 2020 edition of the Journal of Medical Device Regulation Brazilian medical device regulatory expert Luciano Oliveira Ferreira joins Editorial Advisory Board of Journal of Medical Device Regulation Cordis RA expert Elena Jugo joins Editorial Advisory Board of Journal of Medical Device Regulation Datuk Dr Mukundan Sugunan Pillay from Ministry of Health, Malaysia joins Editorial Advisory Board of Journal of Medical Device Regulation December’s Regulatory Bulletin is now available Digital Health, Australia’s regulatory reforms, Chile’s device regulations, and a 3-step approach for manufacturers to prioritise their MDs and IVDs for compliance with the new EU Regulations now available from the Journal of Medical Device Regulation Dr Sergio J Gadaleta Joins Editorial Advisory Board of Journal of Medical Device Regulation Editorial Calendar for 2024 now available Editorial Calendar for 2026 Edward C. Wilson Jr announces retirement and resigns from the Editorial Advisory Board of the Journal of Medical Device Regulation EMEA To Play A Bigger Role In Regulatory Development Process Essential information on clinical evidence, product liability, the new role of Notified Bodies, and Zimbabwe’s medical device regulations are now available in the Journal of Medical Device Regulation’s November issue Essentials for medical device regulatory professionals now available from the Journal of Medical Device Regulation: regulatory development in Eurasia, guidance on the use of RWE, MD regulations in Vietnam, and obtaining CFSs in Europe Everything manufacturers need to know about the new EU IVDR, requirements for new interactions with Notified Bodies for combination products, promotion of devices in the USA through new media, medical reversals and retractions in clinical evaluations, and updated rules for Argentina now available from the Journal of Medical Device Regulation Everything medical device professionals need to know about promised outcomes of the EU’s MDR, critical issues facing implementation of the EU IVDR, the impact of China’s Order 739 on medical devices, and updated regulations for Thailand now available from the Journal of Medical Device Regulation Expanding the understanding of the classification system described by the European Medical Devices Directive: New guidance document published by Global Regulatory Press Free articles section added to the Bookstore of the Journal of Medical Device Regulation Free Podcast: Cybersecurity challenges and opportunities for medical device companies in 2022 Free Podcast: Q&A session on clinical and regulatory challenges for manufacturers under the EU MDR Free Podcast: Q&A session on requirements for SaMD and AI/ML in medical devices FREE Podcast: The many ambiguities of the European Union’s Artificial Intelligence Act Free Podcast: US FDA Pre-Submission Best Practices for Early-Stage Startups and Small Businesses Free Podcast: What’s allowed – and what’s not – when marketing medical devices online? Free Podcasts: Conversations about Regulatory Education initiatives FREE webinar recording: The UKCA – Now, Next, Navigating Ahead How far can the validity of ‘piggy-backed’ products be stretched? Ilona Putz joins the Editorial Advisory Board of the Journal of Medical Device Regulation Insights on the new Person Responsible for Regulatory Compliance under the European MDR/IVDR, Own Brand Labelling under the MDR, Argentina’s device regulations, and a proposition for Basic Environmental Performance Requirements now available from the Journal of Medical Device Regulation International RA expert David Jefferys joins Editorial Advisory Board of Journal of Medical Device Regulation Introducing the fundamentals of European medical device regulations – the Journal of Medical Device Regulation publishes an update of A Beginners’ Guide to the European Medical Devices Directive (MDD) JMDR Editorial Advisory Board Members to Speak at Upcoming Regulatory Events Jorge Garcia from JMDR Editorial Advisory Board to attend 10th Global Harmonisation Task Force Conference Juan Olivares Leon joins the Journal of Medical Device Regulation as Editorial Correspondent for South America Just released: Important information for European Class I medical device manufacturers, a summary of current Post-Market Clinical Follow-Up requirements, Vietnam’s device regulations, and more essential articles now available from the Journal of Medical Device Regulation Kostenloser Podcast – FEMTECH: Innovationen und Herausforderungen in der Regulierung Launch of the Journal of Medical Device Regulation Leading healthcare communications expert Mario R Nacinovich joins Editorial Advisory Board of Journal of Medical Device Regulation Media Guide for 2026 Michael S. Heyl Joins the Editorial Board of the Journal of Medical Device Regulation New emerging medical device market and its regulations: South Korea Paul Sim retires from the Editorial Board of the Journal of Medical Device Regulation Podcast: Current challenges facing the medical device industry in Germany Podcast: How should manufacturers update their QMS to meet the requirements of the European MDR? Podcast: Q&A session on regulatory requirements for medical devices and IVDs in Ecuador Podcast: Supporting the medtech industry to achieve its climate protection and sustainability goals Podcast: The impact of COVID-19, as well as current and future challenges, for the Australian TGA Podcast: The importance of medical device sustainability President of the Brazilian and Latin America Regulatory Affairs Professional Society, Eliana Silva de Moraes, joins the Editorial Board of the Journal of Medical Device Regulation Publication of Revisions to the European Medical Device Directive Expected By End of 2007 Regulatory Bulletin – July 2021 Regulatory Bulletin – September/October 2021 Regulatory Bulletin for December 2022/January 2023 is now available for subscribers Regulatory Bulletin for June / July 2023 is now available for subscribers Regulatory Bulletin for June / July 2024 is now available for subscribers Regulatory Bulletin for June/July is now available for subscribers Regulatory Bulletin for March / April 2023 is now available for subscribers Regulatory Bulletin for March/April is now available for subscribers Regulatory Bulletin for September/October is now available for subscribers Regulatory Bulletin June 2021 Sneak preview of the upcoming February issue of the JMDR Sneak preview of the upcoming November issue of the JMDR The impact of the new EU Market Surveillance Regulation, China’s regulatory reforms in 2020, Advertising under the European MDR/IVDR, Classification of borderline devices, Egypt’s device regulations, and an Analysis of the new US guidance on nitinol-containing medical devices now available from the Journal of Medical Device Regulation The Journal of Medical Device Regulation (JMDR) is proud to announce its upgraded website focusing on customer friendliness and usability The Journal of Medical Device Regulation has a new look The Journal of Medical Device Regulation welcomes Dr Christina Zimmer from the German Medical Technology Association BVMed as new Editorial Advisory Board member The Journal of Medical Device Regulation welcomes Karen Zhou from Northeastern University as new Editorial Board member The Journal of Medical Device Regulation welcomes Teresa Perry from LNE-GMED UK as its new Editorial Board member The Journal of Medical Device Regulation welcomes Val Theisz from the Medical Technology Association of Australia, MTAA, as a new Editorial Board member Updates on the ASEAN Medical Device Directive, the US Breakthrough Devices Program and the Safer Technologies Program, Thailand’s device regulations, and the European GSPRs now available from the Journal of Medical Device Regulation Views and positions on current regulatory issues from the US FDA, the American Dental Association, the Italian Medical Device Manufacturers Association and many more now available in the August 2020 edition of the Journal of Medical Device Regulation Vigilance is Not Enough We have a new CORE: a subscription licence for 2 people Write for us – Editorial Calendar for 2025 out now
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