ISO 14971-Risk Management Standards Revisions

This 90-minute accredited training will offer attendees new insight into the recent changes made regarding the ISO 14971-Risk Management Standards. It will help professionals focus on the significant revisions that need close attention and will give a good explanation as to how the older risk management standards can be made current with the newest interpretation in the most efficient and effective manner. What the medical device industry struggles with however is how to handle extensive documentation to older versions of ISO 14971:2012; this course can provide you some tools (with use of disclaimer statements, etc.) how to revise older versions of your risk management files. Finally, this course takes a peek at some of the “position papers” of some Notified Bodies interpretations on the newly revised standard and will assist you in understanding these changes.