Achieve MDSAP Certification with Confidence
What is MDSAP Certification?
MDSAP (Medical Device Single Audit Program) certification is a global regulatory audit program that allows medical device manufacturers to demonstrate compliance with the quality management system and regulatory requirements of multiple authorities through a single audit.
Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP integrates ISO 13485 with country-specific regulatory requirements from:
- Technology and SaaS companies
- Cloud service providers and data centers
- Financial services and fintech organizations
- Healthcare and life sciences companies
- Professional services firms
- E-commerce and retail businesses
- Managed service providers (MSPs)
- Government contractors and regulated suppliers
Organizations achieve MDSAP certification by successfully completing an independent third-party audit conducted by an authorized MDSAP Auditing Organization (AO). MDSAP certification demonstrates regulatory compliance, audit readiness, and a strong commitment to patient safety.
Benefits of MDSAP Certification
Implementing an MDSAP-compliant quality management system provides critical regulatory and business advantages
Global regulatory compliance
Meet the requirements of multiple regulatory authorities through a single audit
Mandatory market access
Required for Health Canada medical device licensing
Reduced audit burden
Replace multiple regulatory audits with one structured MDSAP audit
Improved inspection readiness
Strengthen FDA inspection outcomes and reduce enforcement risk
Stronger quality system performance
Improve communication and empower teams to participate in process improvement.
Regulatory confidence
Demonstrate compliance maturity to regulators, partners, and customers
Who Needs ISO 27001 Certification?
MDSAP certification is intended for medical device and IVD manufacturers that market or plan to market products in one or more MDSAP participating countries.
MDSAP is especially critical for:
- Medical device manufacturers selling 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 ISO MDSAP Certification
Align the QMS to MDSAP requirements
Assess your current food safety practices against ISO 22000 requirements and HACCP principles.
Conduct internal audits
Perform internal audits aligned to the MDSAP audit model.
Select an MDSAP Auditing Organization (AO)
Engage an authorized third-party audit body.
Complete the MDSAP audit
Successfully pass Stage 1 and Stage 2 audits.
Maintain certification
Address nonconformities and complete annual surveillance audits.
MDSAP certificates are typically valid for three years, with annual surveillance audits required to maintain compliance.
Get Started with MDSAP Certification Today
Ready to take the next step toward MDSAP certification?
Contact PillarStone Quality Consulting today for a free consultation.