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Home > ETQ > How to Prepare for FDA Migration

How to Prepare for FDA Migration

White Paper Published By: ETQ
Published:  Jul 10, 2019
Type:  White Paper
Length:  5 pages

The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in 2019.  In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019.

Download this paper to learn more about these two changes from the U.S. Food and Drug Administrationís proposal to harmonize and modernize its Quality System Regulation (QSR).


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