The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple global authorities. Conducted by recognized Auditing Organizations, the audit evaluates the organization’s quality management system against standards such as ISO 13485:2016 and regulatory requirements from the U.S. FDA, Brazil ANVISA, Japan MHLW, and Australia TGA. This program supports regulatory harmonization, reduces audit duplication, and helps organizations streamline compliance across multiple jurisdictions.