10 Things You Should Know About The Medical Device Single-Audit Pilot
This article was originally published in The Gray Sheet
After a long build up, four international regulatory authorities officially rolled out the Medical Device Single Audit Program pilot this month. Here are 10 things companies should know about the program.
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The agency has terminated a 2012-launched ISO 13485 voluntary audit program, which gave companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.