MDSAP - Medical Device Single Audit Program in Germany
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) streamlines the regulatory audit process for medical device manufacturers by allowing a single audit to satisfy the requirements of multiple international markets. Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP audits cover ISO 13485:2016 and specific regulatory requirements from participating countries.
With MDSAP, manufacturers can ensure compliance with the laws and standards of up to five major medical device markets: Australia, Brazil, Canada, Japan, and the United States.
MDSAP and ISO 13485: What’s the Difference?
While MDSAP builds upon the foundation of ISO 13485, it introduces more stringent requirements. Both programs emphasize the production of medical devices that meet strict quality standards to ensure safety and efficacy for end users.
Companies participating in the MDSAP program must undergo a rigorous audit process to demonstrate compliance with both ISO 13485 and the regulatory frameworks of participating countries. This dual compliance ensures manufacturers benefit from streamlined certification and global market access.
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Regulatory Authorities Participating in MDSAP
- Australia (TGA: Therapeutic Goods Administration of Australia)
- Brazil (ANVISA: Brazil’s Agência Nacional de Vigilância Sanitária)
- Canada (Health CANADA)
- Japan (MHLW: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency)
- USA (FDA: Food and Drug Administration)
Benefits of MDSAP Certification for German Manufacturers
- Save Time and Resources: Consolidates multiple regulatory audits into one comprehensive process.
- Enhanced Efficiency: Simplifies global compliance with fewer audits and inspections.
- Clarity and Transparency: Ensures regulatory requirements are well understood and met.
- Reliable Audit Schedule: Establishes a predictable audit timeline, reducing disruptions.
- Global Market Access: Opens doors to major international markets with one certification.
Our Role in MDSAP Certification Process
Step 1: Goal Setting
We begin by understanding your organization’s needs and objectives for MDSAP certification. Our team will provide a tailored proposal aligned with your specific requirements.
Step 2: Project Planning
In this phase, we conduct a pre-audit to identify potential gaps in your Quality Management System (QMS). This helps us plan and schedule the official audit procedures effectively.
Step 3: QMS Assessment and Implementation
We assist with:
- Training: Empowering your team to understand and implement MDSAP requirements.
- Documentation: Creating and refining essential documents to align with regulatory standards.
- Regulatory Compliance: Ensuring your QMS meets the standards of both MDSAP and ISO 13485.
Step 4: System Evaluation and Certification
Once all requirements are met, we guide you through the final audit process. Upon successful assessment and approval, you will receive your MDSAP certification.
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