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ETQ White Paper
How to Prepare for FDA Migration from QSR to ISO 13485 and QSIT to MDSAP

The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in April 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 Administration’s proposal to harmonize and modernize its Quality System Regulation (QSR).


 

Download the Whitepaper