Are you ready for ISO 14971:2019?
There are several changes to ISO 14971 from the second revision in 2007 to the third revision in 2019. There will be no transition period. Upon release, the third revision (2019) will cancel and remove the second revision (2007). New terms and definitions are introduced, there are changes to the risk management process, postmarket activities are detailed, and whole annexes are removed. You should be prepared to comply with the new ISO 14971:2019.
- Changes to the risk management process
- Changes to the definitions of terms and new terms
- Where to find the guidance to safety characterization?
- Requirements for production and post-production activities
- Transfer of information to ISO/TR24971
- What to do when your analysis shows that your risks are unacceptable?
- Changes to the risk management process
- New definitions of terms
- New terms
- Removal of annexes
- Transfer of information to ISO/TR24971
- Requirements for production and post-production activities
- Clarifications in the language of the Standard
- Guidance on when the residual risk is not acceptable
To become aware of the upcoming changes to the central standard of risk management for medical devices
- Quality assurance
- Design engineering
- Regulatory affairs
- Clinical investigations
- Risk management
Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. Bijan started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990s.
He is a corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide.
He is also a lecturer at the Delft University of Technology, and the Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He 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 book Safety Risk Management for Medical Devices.
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