Webinar instructor: Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing
The third revision of ISO 14971 was approved and released in Q4, 2019. Upon release it cancels and replaces ISO 14971:2007. There are a number of changes to ISO 14971 from the second revision in 2007 to the third revision in 2019. This presentation will look at the risk management process highlighting changes as well as the method for the evaluation of the overall residual risk and the criteria for its acceptability. New terms will be identified such as benefit, reasonably foreseeable misuse and state of the art as well as definition changes to existing terms. The elimination of a number of annexes in ISO 14971 and their transferred to ISO/TR 24971 will be discussed.