The ABC’s Of Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to enable audits that encompass ISO 13485 as well as the regulatory requirements from the United States, Canada, Australia, Brazil and Japan. The program offers many benefits, including an overall reduction in the number of audits and corresponding reduction in the disruptions to operations, increased confidence in audit preparedness, and a platform to expedite entry into global markets.