Stepping into an MDSAP audit

The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch on January 2017 of a fully Operational MDSAP program.

The program has it stands is built around a standardized audit and assessment models approach to ensure harmonization of practices amongst Auditing Organizations (AOs) such as LNE/GMED, and meet the expectations of medical device manufacturers looking to leverage the use of their regulatory resources in a unique audit.

The Medical Device Single Audit Program (MDSAP) is a regulatory program unique in its ability to facilitate access to the USA, Canada, Brazil, Japan and Australia; offering thus the possibility for companies to be assessed in the course of one single Quality Management System ( QMS) audit for up to 5 regulations at once, a program highly suitable for those selling or planning on selling medical devices into these 5 international jurisdictions.