MDSAP Lead Auditor Training - International MDSAP Audit Approach

This five-day training course covers the requirements of the international Medical Device Single Audit Program (MDSAP) Audit Approach, as well as the methods to audit the regulations for conformity and the requirements for Auditing Organizations. This course is intended for those who plan to become a third-party MDSAP auditor, or those serving as lead auditors of their internal audit teams.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This course is designed for those that are already experienced and have been trained on ISO 13485. While the linkages to ISO 13485 requirements will be discussed, the 13485 requirements are not covered in depth.