Medical Device Single Audit Program | MDSAP Consulting in Germany

What is MDSAP?

MDSAP is a Medical Device Single Audit Program that allows the conduct of a single regulatory audit of a medical device manufacturer’s QMS that satisfies various regulatory jurisdictions. This program was developed by a group of medical device regulators, the IMDRF, to allow third-party auditors to conduct this single audit of medical device manufacturers which covers ISO 13485:2016 and respective regulatory requirements.

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.

MDSAP and ISO 13485

MDSAP has more stringent requirements than ISO 13485. ISO 13485 and MDSAP are two different programs with similar requirements. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO 13485 MDSAP standards look to ensure that medical devices are 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 to profit from the program.

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Regulatory Authorities Included 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)

The Benefits of MDSAP Certification

Time-saving and efficiency
Clarity and transparency
Reduces the number of audits and inspections
Reliable audit schedule

Our Role in MDSAP Certification Process

Defining the goals: To start with the first step we discuss with you about the 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 the step where we do a pre-audit, which helps us to identify the improvement potential of QMS in advance. This pre-audit meeting helps us in planning and scheduling the audit procedures.
QMS 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 the creation of documents.
System evaluation: You acquire your MDSAP certificate if all requirements are satisfied and the assessor’s recommendation for certification is confirmed.

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