A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes. BioWorld MedTech ...
MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited ...
Additionally, the company is aiming to secure the Medical Device Single Audit Program (MDSAP) certification by this year. The MDSAP allows for a unified audit process across the US, Japan ...
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