ISO 14971:2019 - Application of Risk Management to Medical Devices Speaker: Bob Deysher - Senior Consultant, QSG
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.
Bob Deysher - Senior Consultant, QSGBob has over 40 years of manufacturing experience in the semiconductor industry. In that time he has held senior management positions in industrial engineering, process engineering, package assembly, manufacturing, quality, and reliability. He has also worked as a senior staff member and consulting engineer in quality and reliability in between senior managerial assignments.
At QSG, Bob’s areas of training and consulting include ISO 9001 & AS9100, Toyota Production System (TPS) and Lean, Corrective Action and Problem Solving (8D), as well as Risk Based Thinking (RBT), ISO 31000, and ISO 14971
Bob has a B.S. and M.S. in Metallurgy and Material Science from Lehigh University.
DATE: 5/7/20 TIME: 12 PM EDT DURATION: 60 Minutes