Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on 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.
Fully owned subsidiary of GMED SAS. • GMED, Notified Body n° 0459
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