MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) TRAINING – upon request

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to combine the requirements of 5 jurisdictions within a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States are participating in the program. In this training, the background of MDSAP, the concept and the audit process including grading of non-conformities and post-audit follow-up activities will be introduced to you. Within 4 hours, you will receive a comprehensive summary concerning the fundamentals of the MDSAP and the potential advantages of adhering to the program. Furthermore, you will receive expert tips on how you can prepare your organization in the most efficient manner.

• Opening remarks
• Introduction to MDSAP Background/Concept/Participating countries
• MDSAP Audit Model
• MDSAP Audit Process
• Audit Time Calculation
• MDSAP Grading
• Post-Audit Follow-up Activities
• Q&A session
• Closing remarks

• Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided.