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
{accountaddress}
You are receiving this email because you agreed to receive newsletters and/or you are customer of GMED North America, Inc. If you no longer wish to receive these messages, click here.
We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States