MDSAP Training Courses on the IMDRF's Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP Training) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. It is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States.

Comply Guru offer the following types of MDSAP training courses depending on the target audience and/or learning objectives, including:

1. Auditor Foundation Training is for those who need to gain an understanding of the MDSAP and the Audit Approach.
2. Auditor Skills Training is for those who want to conduct an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.