Understanding MDSAP Audit Guidance for Medical Device Manufacturers

 The Medical Device Single Audit Program, or MDSAP, is a comprehensive and globally recognized initiative aimed at streamlining the regulatory audit process for medical device manufacturers. This program was developed by the International Medical Device Regulators Forum (IMDRF) to create a harmonized approach to audits, ensuring consistent quality and safety standards across multiple jurisdictions. To navigate this intricate landscape, manufacturers need to adhere to MDSAP Audit Guidance, a set of principles and recommendations that guide them through the audit process.