The Medical Device Single Audit Program (MDSAP): Your Questions Answered
Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019, and as of late 2019, nearly half of US manufacturers qualified for an MDSAP audit while the rest received traditional FDA inspections. At Oriel STAT A MATRIX we get many questions about MDSAP, […]
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