What is MDSAP?
Recognizing that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonized approach to auditing and monitoring the manufacturing of medical devices.
This new approach is designed with a goal of improving medical device safety as well as oversight of medical device manufacturing on an international scale. As a result, the Medical Device Single Audit Program or MDSAP was established.
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