ISO 13485:2016 Transition

This self-paced gives you an in-depth look at the requirements of ISO 13485 with emphasis on the changes introduced in the 2016 version.  It will start with the reasons for the change, go over each clause in details, and conclude with useful recommendations.  This course is essential for responsible for only sections of the process, those required to implement the whole QMS based on the standard, or perform internal audits to access conformity with the standard.

Take this Course