Medical Device Single Audit Program (MDSAP)

Participating regulatory agencies in the MDSAP program include:

• Australian Therapeutic Goods Administration (TGA)
   
• Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
   
• Health Canada
   
• Japan’s Ministry of Health, Labour and Welfare (MHLW)
   
• United States Food and Drug Administration (FDA)
   

This streamlined audit process reduces the burden on manufacturers by eliminating the need for separate audits for each regulatory body, facilitating global market access and enhancing compliance efficiency.

RAPS – Your Partner for Seamless MDSAP Compliance

Navigating multi-agency audits can be complex, but with RAPS, you get expert guidance and hands-on support to help you:

 Prepare for and pass MDSAP audits confidently
Align your quality systems with international standards
Streamline regulatory approvals across key markets

Ready to simplify your audit process?
Contact RAPS today and take the first step toward hassle-free MDSAP certification.

The MDSAP framework is based on ISO 13485:2016, aligned with the Good Manufacturing Practice (GMP) requirements of participating regulatory authorities. This unified approach ensures compliance with global standards while addressing the specific needs of each regulatory body.

MDSAP covers seven major processes:

1. Management
    
2. Measurement, Analysis, and Improvement
    
3. Design and Development
    
4. Production and Service Controls
    
5. Purchasing
    
6. Device Marketing Authorization and Facility Registration
    
7. Medical Device Events and Advisory Notices Reporting
    

• Eliminate the need for multiple audits by different Certification Bodies in a single year.
   
• Minimize business disruptions, reduce costs, and save time through an efficient, single-audit process.
   
• Accelerate market entry by overcoming delays often caused by traditional regulatory oversight.
   
• Maintain unified and integrated documentation onsite, reducing paperwork and duplication.
   

Our qualified MDSAP lead auditors and experienced consultants provide:

• On-site and off-site documentation support
   
• MDSAP awareness and internal quality audit (IQA) training for employees
   
• Support for initial internal audits to ensure readiness
   

• Gap Assessment: $700 USD / Man-day
   
• Guidance & Support for Gap Closure: $400 USD / Man-day
   
• Internal Audit: $600 USD / Man-day
   

For a detailed quote and personalized consultation

Ready to Streamline Your Medical Device Audits? With RAPS as your trusted partner, you can simplify the complex MDSAP process, reduce audit fatigue, and accelerate your global market access.   Contact us today to get expert support, comprehensive training, and tailored consulting—so you’re fully prepared for MDSAP certification success.  Make compliance easier. Make RAPS your partner.