White Paper: Medical
How to Prepare for FDA Migration to ISO 13485 and QSIT to MDSAP
The FDA 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 the implications of these two changes and how to prepare for them.