This course will provide the information and tools you need to understand the requirements of ISO 13485:2016.

Test123

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Nam libero […]

MDSAP Overview:  The Medical Device Single Audit Program (MDSAP) is a program where Auditing Organizations (AO) conduct a single audit of a medical device manufacturer’s quality management system that would be accepted by all five Regulatory Authorities currently participating in the program, Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW. The program […]

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, […]