The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.
Learn what are the changes to ISO 14971 and be prepared, when it is released.There is no transition period.Upon release, the 2019 revision will cancel and remove the 2007 revision.
Why Should You Attend:
There are a number of 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.Learn what are the changes to ISO 14971 and be prepared, when it is released.There is no transition period.Upon release, the 2019 revision will cancel and remove the 2007 revision.
Areas Covered in the Webinar:
- 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 in not acceptable
Who Will Benefit:
- Design engineers
- Research engineers
- Quality assurance/Quality engineers
- Regulatory
- Clinical
- From the medical device and pharma industries.
Speaker
Bijan ElahiCourse Provider
Bijan Elahi,
