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Compliance Corner: Leverage MDSAP Companion Doc To Master Your Next Audit, Train Staff, Expert Advises

 
• By Shawn M. Schmitt

Longtime industry expert Connie Hoy says medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document. The doc can also be used to train workers on what an MDSAP auditor will be looking at and asking for.

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Medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document and training staff on its relevant parts, an industry expert advises.

MDSAP, created by the International Medical Device Regulators Forum (IMDRF), allows firms to undergo one audit by an accredited third party to satisfy quality regulations for the US, Canada, Brazil,...

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