Medical Device Single Audit Program (MDSAP)
Achieve Global Market Access with Expert MDSAP Implementation & Compliance Support
As the global regulatory landscape for medical devices becomes more stringent, manufacturers in the Netherlands must adopt internationally recognized quality management systems to access global markets efficiently. The Medical Device Single Audit Program (MDSAP) offers a streamlined path to regulatory compliance across multiple countries through a single audit process. At Operon Strategist, we help medical device manufacturers in the Netherlands successfully implement MDSAP and align their Quality Management System (QMS) with global regulatory requirements. Our experts bring proven experience in regulatory consulting, international audits, and QMS development positioning your business for long-term success and market expansion.
What is MDSAP?
MDSAP stands for Medical Device Single Audit Program that allows the conduct of single regulatory audit of medical device manufacturer’s QMS that satisfies various regulatory jurisdiction. This program was developed by a group of medical device regulators, the IMDRF, to allow the third-party auditors to conduct this single audit of medical device manufacturers which covers ISO13485:2016 and respective regulatory requirement.
MDSAP is a mechanism for producers of medical devices to have their compliance with the standards and laws of up to five distinct medical device markets, including Australia, Brazil, Canada, Japan, and the United States, audited once. The goal of MDSAP is to make it possible to conduct a single regulatory audit of a medical device manufacturer’s quality management system.
The Benefits of MDSAP Certification:
- Time saving and efficiency
- Clarity and transparency
- Reduces number of audits and inspections
- Reliable audit schedule
Medical Device Single Audit Program (MDSAP) and ISO13485
MDSAP has more stringent requirement than ISO13485. ISO 13485 and MDSAP two different programs with similar requirement. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO13485 MDSAP standards look to ensure that medical device manufactured to strict quality requirements. Companies that participate in the MDSAP program must undergo an audit to ensure compliance with both regulatory and ISO 13485 requirements in order to profit from the program.
MDSAP Countries and Regulatory Authorities Include:
- 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)
What Is the Criteria That Must Be Achieved for the MDSAP to Be Considered Successful?
The success of the Medical Device Single Audit Program (MDSAP) is determined by meeting specific benchmarks established by the MDSAP Subject Matter Experts Working Group. They have developed a data acquisition strategy to validate the program’s “proof of concept,” comprising eight performance metrics for evaluating progress. These metrics pertain to audit reports, non-conformities, audit methodology, required audit volume, auditing entities, and manufacturer involvement. Each metric has defined criteria for data collection, sampling, analysis techniques, and goals. The proven functionality of the MDSAP program underscores its success in achieving these objectives.
Operon Strategist Role in MDSAP Certification Process:
- Defining the goals: To start with first step we discuss with you about company and the benefit of MDSAP certification. You will receive a specific offer tailored to the need of your company or organization
- Project planning: project planning is step where we do pre audit, which is help us to identify improvement potential of QMS in advance. These pre audit meeting helps us in planning and scheduling audit procedure.
- Quality Management System Assessment: while assessing this step we guide and provide training to our clients to implement QMS as per the required regulations and we also help them in creation of documents.
- System evaluation: You acquire your MDSAP certificate if all requirements are satisfied and the assessor’s recommendation for certification is confirmed.
One Audit. Multiple Markets. Begin Your MDSAP Compliance with Operon Strategist Today!
FAQs
1. What is MDSAP, and why is it important?
MDSAP (Medical Device Single Audit Program) is an initiative that allows medical device manufacturers to undergo a single regulatory audit that is recognized by multiple participating countries (USA, Canada, Australia, Brazil, and Japan). It reduces audit redundancy and streamlines compliance with international regulatory requirements.
2. Who needs MDSAP certification?
Medical device manufacturers looking to market their products in MDSAP-recognized countries must obtain MDSAP certification to demonstrate compliance with regulatory requirements in those regions.
3. How does Operon Strategist help with MDSAP compliance?
Operon Strategist provides comprehensive support, including gap analysis, QMS implementation, documentation review, audit preparation, and post-audit corrective action planning to ensure a smooth MDSAP certification process.
4. What are the key requirements for MDSAP certification?
The key requirements include compliance with ISO 13485:2016, country-specific regulatory requirements, an established quality management system, risk management procedures, and audit readiness.
5. How long does it take to get MDSAP certification?
The timeline varies depending on the company’s readiness and the complexity of its QMS, but typically, the MDSAP certification process can take anywhere from 6 to 12 months.