MDSAP (Medical Device Single Audit Program)

MDSAP is a comprehensive audit program that enables medical device manufacturers to demonstrate compliance with regulatory requirements across multiple global markets including the US, Canada, Japan, and Brazil. The program streamlines the audit process, reducing time and cost while ensuring devices meet stringent safety and quality standards. MDSAP certification accelerates market entry and strengthens regulatory confidence for medical devices and IVDs.

Medical Device Single Audit Program (MDSAP) audit and certification service for medical device manufacturers seeking global regulatory compliance. BSI provides recognized auditing and conformity assessment across multiple international markets to verify device safety, quality, and performance standards. Enables manufacturers to streamline multi-market regulatory submissions and demonstrate compliance with ISO 13485 and regional medical device requirements.

Comprehensive quality management systems and auditing services for medical devices, including MDSAP (Medical Device Single Audit Program) certification. Supports regulatory compliance across multiple jurisdictions through expert laboratory testing and analytical validation across 950+ facilities worldwide.