Medical Device Single Audit Program (MDSAP)

The MDSAP Audit Approach and MDSAP Certification are managed by the International Medical Device Regulatory Forum (IMDRF). The MDSAP Audit Approach is developed to assess the conformance of Medical Device Manufacturers to ISO 13485:2016 Quality Management System (QMS) requirements and their compliance with regulatory requirements in the markets where they sell products. This assessment is conducted in a single audit.

The MDSAP audits and auditor training are designed to ensure conformance with ISO 13485:2016 requirements and compliance with jurisdictional Regulatory Authorities (RAs) and country-specific requirements. Audits for MDSAP Certification are carried out by the Auditing Organizations approved by the IMDRF. MDSAP certifications are recognized by Regulatory Authorities in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States of America (FDA).

Why MDSAP Certification?

The MDSAP Audit Approach is employed by the Auditing Organizations and Medical Device Manufacturers to conduct combined conformance and compliance audit of the manufacturer’s Quality Management System, eliminating the need for separate ISO 13485 and Regulatory audits.

What is the Difference Between MDSAP & ISO 13485?

• ISO 13485:2016 audit assess conformance to Quality Management System (QMS) requirements. Organizations must have ISO 13485:2016 certification to be eligible for MDSAP audits and certifications.
• The MDSAP Audit Approach assesses both QMS requirements and compliance with relevant regulatory requirements in MDSAP markets.
• MDSAP Auditor training participants should either hold ISO 13485 Auditor Certifications or have a strong understanding of ISO 13485:2016-based QMS.

Why Omnex and How Can We Help?

• OMNEX has been actively engaged in MDSAP Audit methods since the inception of the pilot program. We have conducted numerous MDSAP internal audits, preparing organizations and maintaining their existing certifications.
• OMNEX’s MDSAP Auditor training equips participants to conduct audits of medical device quality management systems, ensuring both conformance and compliance requirements are addressed in a single MDSAP audit.

OMNEX is a Recognized Training Provider for MDSAP by Exemplar Global. We have trained and certified numerous participants to perform internal and external MDSAP audits. Regulatory agencies participating in MDSAP programs are on equal footing. The IMDRF management committee includes members like the European Union, Russia, Singapore, South Korea, and the United Kingdom. Observers of the MDSAP Audit Approach include Argentina (NAD/FMD), the World Health Organization (WHO), and Switzerland (Swissmedic), which paves the way for wider global acceptance of MDSAP Certification.