Medical Device Single Audit Program (MDSAP)

ABOUT THE COURSE

The Medical Device Single Audit Program (MDSAP) 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.  Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. 

YOUR BENEFITS

MDSAP 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.  The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” 

course content/outline

The MDSAP Training program shall cover the following modules:

• Introduction to MDSAP, management and measurement
• Analysis and improvement
• Design and development and production
• Service controls, purchasing
• Device marketing authorization and facility registration
• Medical device adverse events and advisory notices
• Country specific requirements - USA, Brazil, Australia, Canada and Japan

WHO SHOULD ATTEND?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.

Training Duration

02 Days

PRE-REQUISITES

Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.

Certification

An attendance certificate would be provided to the participants on successful completion of the training program.