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Latest ISO Medical Device Developments: Real-World Impact on Regulatory, Quality & Compliance Specialists
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Your quality management system (QMS) should be closely linked to changing U.S. and international regulatory standards for your device to ensure compliance and maintain a competitive edge:
- ISO 13485 has just been reconfirmed for five more years
- The FDA intends to replace 21 CFR 820 with ISO 13485 later this year
- ISO 13485 is used as the basis of MDSAP
- Work is in progress to document the relationship between the content of ISO 13485 with the regulatory requirements in the EU-MDR
- The Association for the Advancement of Medical Instrumentation (AAMI) published its technical information report (TIR) 102, which maps to ISO 13485:2016
- Wider developments in standards for generic QMS requirements in ISO 9001 could impact those for medical devices
Eamonn Hoxey, a technical author, trainer and consultant in life science, will explain the interrelationship between these initiatives and the future direction of QMS requirements for your medical devices.
Key Presentation Takeaways:
- The relationship between ISO 13485 and 21 CFR 820
- The relationship between ISO 13485 and the EU MDR requirements
- Implications of the reconfirmation of ISO 13485:2016 on QMS requirements for medical devices
- How ISO 13485 is used in MDSAP
- The future direction of generic management system requirements to include ISO 9001
Understand the changing landscape of ISO medical device developments to develop the direction of your QMS.
Meet Your Presenter:
Eamonn Hoxey is a technical author, trainer and consultant in a range of life science areas including regulatory compliance, quality management, standards development and sterility assurance. He worked for Johnson & Johnson for 17 years in positions of increasing responsibility in quality and regulatory compliance for medical devices, pharmaceuticals and consumer products, including Vice President of Compliance, Vice President of Market Quality and lead quality implementation for EU medical devices regulation for the company’s medical devices companies. Prior to joining Johnson & Johnson, Mr. Hoxey spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety. He is past chair of ISO TC 210 (quality management and related general aspects for medical devices) and ISO TC 198 (sterilization of healthcare products). He has participated actively in the development of European and International standards for sterilization and quality management systems, including ISO 9001:2015 and ISO 13485:2016. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.
Who Will Benefit:
- Quality Systems
- Quality Management Systems
- Regulatory Compliance
- Regulatory Affairs