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What Is It? The Medical Device Single Audit Program (MDSAP) is a global approach to auditing and monitoring the manufacturing and safety of medical devices on an international scale. It allows a recognised Auditing Organisation to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are participating in the MDSAP include: MDSAP Members: Therapeutic Goods Administration of Australia Brazil’s Agência Nacional de Vigilância Sanitária Health Canada Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency U.S. Food and Drug Administration MDSAP Official Observers: Europe...

Product Conformity Assessment involves testing and certification processes to show that your product, service or system meets the requirements of a standard. It demonstrates that a medical device is designed and produced to be safe, fit for purpose and perform as intended. At Wiselink, we are able to identify the most suitable product quality standard on an international scale for your medical device. We will organise testing and certification with the corresponding regulatory authority. By choosing Wiselink, you will receive reliable consultancy and efficient services. The benefits of undergoing a medical device conformity assessment: Provide consumers and other stakeholders with added confidence Give your company a competitive edge Help regulators ensure th...