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10 July 2019 - news

MDSAP Certification

We are extremely proud to announce that DIESSE has received the Medical Device Single Audit Program (MDSAP) certification issued by TÜV SÜD America.

The MDSAP is the latest Medical Device industry quality standard which define medical device manufacturers' quality management system standard, as well as those for design and development, purchasing, manufacturing processes, distribution, service and post-marketing surveillance.

DIESSE has obtained the Certification which covers the requirements of all five agencies participating in the program:

- Australia’s Therapeutic Goods Administration of Australia (TGA)
- Brazilian Agência Nacional de vigilância sanitária (ANVISA)
- Japan's Ministry of Health, Labour and Welfare (MHLW)
- Health Canada
- United States Food and Drug Administration (FDA).

MDSAP is a milestone for regulatory compliance globally. This accomplishment re-emphasizes DIESSSE’s on-going commitment to deliver quality products and services to our customers