Achieve MDSAP Certification with Confidence
What is MDSAP Certification?
MDSAP (Medical Device Single Audit Program) certification is a premier global regulatory audit program . it allows medical device manufacturers to demonstrate comprehensive compliance with the quality management system (QMS) and regulatory requirements of multiple international authorities through a single, unified audit.
Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP seamlessly integrates ISO 13485 with country-specific regulatory requirements from the following authorities:
- U.S. FDA
- Health Canada
- Therapeutic Goods Administration (TGA - Australia)
- ANVISA (Brazil)
- PMDA/MHLW (Japan)
Organizations earn certification by successfully completing an independent third-party audit conducted by an authorized MDSAP Auditing Organization (AO). Achieving this standard demonstrates high-level audit readiness and a commitment to patient safety.
Strategic Benefits of MDSAP Certification
Implementing an MDSAP-compliant system provides critical regulatory and business advantages for the medical device industry:
Global Regulatory Compliance
Meet the requirements of multiple international authorities through one single audit.
Mandatory Market Access
MDSAP is a requirement for Health Canada medical device licensing.
Reduced Audit Burden
Replace multiple, exhausting regulatory audits with one structured MDSAP audit.
Improved Inspection Readiness
Strengthen your FDA inspection outcomes and significantly reduce enforcement risk.
Stronger Quality System Performance
Improve internal communication and empower teams to participate in active process improvement.
Regulatory Confidence
Demonstrate high compliance maturity to regulators, partners, and customers.
Who Needs MDSAP Certification?
MDSAP is intended for medical device and IVD manufacturers that market, or plan to market, products in participating countries. It is especially critical for:
- Manufacturers selling products in Canada.
- Companies subject to FDA inspections.
- Organizations expanding into Australia, Brazil, or Japan.
- Manufacturers transitioning from ISO 13485 to MDSAP.
- Companies seeking to reduce regulatory audit fatigue.
Manufacturers with complex operations, multiple sites, or higher-risk devices benefit significantly from MDSAP’s structured, process-based audit model.
How to Get MDSAP Certification
Achieving certification involves a systematic approach to regulatory excellence:
Align the QMS
Assess and align your current quality system to MDSAP requirements.
Conduct Internal Audits
Perform rigorous internal audits specifically aligned to the MDSAP audit model.
Select an Auditing Organization (AO)
Engage an authorized third-party body to perform the assessment.
Complete the MDSAP Audit
Successfully pass both Stage 1 and Stage 2 audits.
Maintain Certification
Address nonconformities and complete annual surveillance audits to ensure the certificate remains valid (typically for three years).
MDSAP certificates are typically valid for three years, with annual surveillance audits required to maintain compliance.
Why Choose PillarStone Quality
Proven MDSAP Framework
Structured, audit-aligned implementation roadmap
Regulatory Expertise
Deep experience with FDA, Health Canada, and global MDSAP authorities
End-to-End Support
From gap analysis through certification and surveillance audits
Cost-Effective Solution
More efficient than hiring and training internal regulatory staff
Audit-Focused Approach
Built around how MDSAP auditors actually audit
Get Started with MDSAP Certification Today
Ready to take the next step toward MDSAP certification?
Contact PillarStone Quality today for a free consultation.