Kim Trautman (Executive Vice President Medical Device International Services, NSF Medical Devices)
Date: Friday, December 4
Time: 10:30 am - 11:30 am
Track:
MedTech Mornings: Product Design & Development
Vault Recording: TBD
The new edition of ISO 14971:2019, Medical devices – Application of risk management to medical devices, was released in December 2019 and has new definitions and updated requirements, as well as three informative annexes. The new ISO TR 24971:2020 was issued in June of 2020 and provides extensive guidance on making risk management a process approach through the lifecycle of medical devices. The EU MDR comes into effect in May 2021 with heightened risk management regulatory requirements both in clinical evaluation as well as post market surveillance. Come and hear about these details and how the IMDRF terminologies and codes for categorized Adverse Event Reporting (AER) might be able to help you bridge the gaps between pre and post market data collections.
Topics covered include:
- An overview of the ISO 14971:2019 changes and how these changes will affect the technical documentation throughout the medical device lifecycle
- Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities
- How to incorporate the IMDRF terminologies and codes for categorized Adverse Event Reporting (AER) into your risk management process through the life cycle of your medical devices
- Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations
