2019 - Are you ready for ISO 14971:2019?

OVERVIEW
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.
LEARNING OBJECTIVES
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?
WHY SHOULD YOU ATTEND
To become aware of the upcoming changes to the central standard of risk management for medical devices
AREAS COVERED
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
WHO WILL BENEFIT?
Quality assurance
Design engineering
Regulatory affairs
Clinical investigations
Risk management
SPEAKER
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.
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