Global Regulatory Requirements – MDSAP-Participating Countries

NSF International is the first organization to launch this interactive and comprehensive training series, providing in-depth knowledge of the premarket and postmarket regulatory requirements of Australia, Brazil, Canada, Japan and the United States, all structured in a consistent format to enhance the learning experience.  
Each two-hour course is fun, highly interactive, and includes knowledge checks and final exams to test your understanding and provide evidence of competency as required by ISO 13485:2016.

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MDSAP Overview Training

This two-hour web-based course offers your organization the flexibility and efficiency of a virtual classroom to prepare for MDSAP.

Presented by Kim Trautman, former U.S. FDA official and key member of the original MDSAP development team, this course teaches the basics of the new nonconformance grading system and what grades trigger regulatory follow-up.

You’ll learn about the MDSAP audit model, audit time calculations, the information to be included in the audit report and the MDSAP timeline. 

This course includes a final exam and a Certificate of Successful Completion, providing evidence of competency as required by ISO 13485:2016. 

Register for the class

For additional information please call +1 202 822 1850