1. Medtech Insight

Time For EU To Become Full Member Of Global Single Audit Program

 
• By Amanda Maxwell

As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.

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Industry Spells Out Advantage Of MDSAP Membership As It Seeks Rapidly Available Regulatory Wins • Source: Alamy

The European medical technology industry, represented by MedTech Europe and COCIR, is urging the EU to become a full member of the Medical Device Single Audit Program (MDSAP) “in a timely manner” to benefit from the regulatory streamlining benefits it offers.

MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the requirements of multiple regulatory authorities.

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