Audits for medical device companies and other organizations in the medtech space used to be primarily in person. However, the pandemic magnified flaws in the global regulatory process. A shift to remote audits may be the key to interorganizational and international regulatory harmonization moving forward.
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
A guide to what to expect during your certification audit and how to prepare.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
The agency wants device manufacturers to participate in the MDSAP Pilot.
The agency continues to take measures to ensure the safety and quality of imported medical devices.