Medical Device Single Audit Program (MDSAP) Compliance
Why Companies Choose NAMSA
Medical Device & IVD Focused
Dedicated Quality and Regulatory Employees on Staff
Year NAMSA Founded to Serve Medical Device Companies
Medical Device Single Audit Program (MDSAP) Support
Achieving MDSAP certification is more than a regulatory requirement—it’s a strategic advantage for medical device manufacturers seeking global market access. At NAMSA, we don’t just guide you through the process; we deliver end-to-end expertise that ensures your Quality Management System (QMS) meets the highest international standards.
Our Regulatory Affairs and Quality Assurance specialists have decades of experience helping manufacturers navigate complex compliance landscapes. With NAMSA, you gain a trusted partner who understands the nuances of FDA, Health Canada, ANVISA, PMDA, and TGA requirements—and knows how to harmonize them efficiently.
Benefits of MDSAP Certification
MDSAP certification offers significant advantages for manufacturers seeking global reach. By meeting MDSAP requirements, manufacturers reduce the likelihood of separate inspections from individual authorities, making global expansion more efficient.
- One MDSAP Audit, Global Reach: Replace multiple country-specific audits with a single, streamlined process recognized by five major regulatory authorities.
- Accelerated Market Access: Enter new markets faster by meeting harmonized requirements upfront.
- Cost Efficiency: Reduce audit redundancies and resource allocation, saving time and money.
- Risk Mitigation: Strengthen your QMS to minimize nonconformities and regulatory findings.
- Brand Credibility: Demonstrate a proactive commitment to quality and patient safety, building trust with regulators and customers.
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Want to learn more about our experience in MDSAP compliance? Wondering how we approach it, how long it will take, and how much it will cost?
NAMSA MDSAP Audit Approach
At NAMSA, our sole mission is to help medical device manufacturers achieve seamless compliance through the Medical Device Single Audit Program (MDSAP). With decades of experience in global regulatory frameworks and ISO 13485:2016 standards, we bring unmatched expertise to guide you through every stage of the MDSAP audit process. Our team understands the complexities of multi-market regulations and knows how to translate them into actionable strategies that ensure success. Our approach is methodical, risk-based, and globally aligned:
- Comprehensive QMS Evaluation: We conduct a thorough assessment of your Quality Management System, covering management responsibility, resource management, product realization, and continuous improvement processes. Our audits are designed to meet ISO 13485:2016 requirements and the specific expectations of FDA, Health Canada, ANVISA, PMDA, and TGA, ensuring your QMS is robust and globally compliant.
- Gap Analysis & Corrective Action Planning: NAMSA identifies compliance gaps early through detailed gap assessments, allowing you to address issues proactively. We help you develop and implement corrective action plans tailored to your organization, minimizing the risk of nonconformities and regulatory findings during the official MDSAP audit.
- MDSAP Mock Audits & Readiness Reviews: Our team simulates real-world audit conditions to prepare your staff and processes for the actual MDSAP audit. These mock audits and readiness reviews reduce surprises, build confidence, and ensure your documentation and practices are audit-ready.
We Deliver a Harmonized MDSAP That Meets International Requirements
NAMSA’s expertise covers all aspects of MDSAP, from understanding the core ISO 13485 requirements to integrating country-specific regulations. The audit process is guided by a standardized checklist that incorporates both general and local requirements, ensuring nothing is overlooked. This harmonized approach reduces the likelihood of unexpected regulatory inspections and simplifies entry into new markets.
Meet Our MDSAP Experts
Explore the depth of our team’s expertise in quality management systems.
Frequently Asked Questions (FAQs)
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a global initiative that allows medical device manufacturers to undergo a single regulatory audit of their quality management system (QMS), satisfying the requirements of five major regulatory authorities: the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and Australia (TGA). This unified approach streamlines compliance and reduces the need for multiple country-specific audits.
Which countries participate in MDSAP?
MDSAP is recognized by the regulatory authorities of the United States, Canada, Brazil, Japan, and Australia. Manufacturers seeking market access in these countries can use a single MDSAP audit to meet all relevant regulatory requirements. Other regions, such as the European Union, may accept MDSAP reports as supporting evidence but are not official participants.
What is the difference between ISO 13485 and MDSAP?
While ISO 13485 is an international standard for medical device QMS, MDSAP incorporates ISO 13485 requirements and adds country-specific regulatory requirements for each participating authority. MDSAP audits are generally more rigorous and detailed, providing a unified approach to regulatory compliance across multiple jurisdictions.
Is MDSAP certification mandatory for all markets?
MDSAP certification is mandatory for medical device manufacturers wishing to sell Class II, III, and IV devices in Canada. In the United States, Brazil, Japan, and Australia, participation is voluntary but highly recommended for streamlined compliance and market access.
How does the MDSAP audit process work?
The MDSAP audit is conducted by authorized Auditing Organizations and follows a risk-based, comprehensive approach. It covers all aspects of the manufacturer’s QMS, including management responsibility, resource management, product realization, and measurement analysis. The audit cycle typically includes an initial certification audit, annual surveillance audits, and a recertification audit every three years.
Does MDSAP cover European Union (EU) requirements?
No, the EU is not a participating member of MDSAP. While MDSAP certification may support global quality recognition, manufacturers seeking EU market access must comply with MDR/IVDR requirements and undergo separate audits.
What is the best way to prepare for an MDSAP audit?
Preparation involves reviewing your quality management system against ISO 13485:2016 and the specific requirements of each MDSAP country. Conducting a gap assessment, updating documentation, training staff, and performing internal mock audits are recommended steps to ensure readiness.
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