MDSAP (Medical Device Single Audit Program for Canada, the United States, Brazil, and Australia)
To those considering entering the medical device market (Canada, the United States, Brazil, Australia)
To those considering entering the medical device market (Canada, the United States, Brazil, Australia): Introducing MDSAP certification.
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basic information
MDSAP is a method that allows medical device manufacturers to undergo a single audit for compliance with the standards and regulatory requirements demanded by regulatory authorities in up to five different medical device markets (Canada, the United States, Brazil, Australia, and Japan).
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Applications/Examples of results
DQSQS Japan has established a consultation desk for those considering obtaining MDSAP. Please feel free to contact our desk representative for future responses and second opinions.
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Company information
DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.