MDSAP- Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries through a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

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A group of people discussing problem
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Change of certifier and/or notified body

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Richtlinie 93/42/EWG für Medizinprodukte
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DQS Medizinprodukte GmbH, Member of DQS Group

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DQS MED presentation slides