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FDA's Single-Audit Point Person Sees Device-Maker Benefits In MDSAP Initiative

Kim Trautman, the FDA official working closely with the International Medical Device Regulators Forum on its Medical Device Single Audit Program pilot, envisions many benefits to industry participation, including easier compliance with international quality systems standard ISO 13485 as well as input on the MDSAP program as a whole, she said in an interview.

Manufacturer input is key to the final design of the Medical Device Single Audit Program, says an FDA official who has been spearheading the agency’s contributions to the international inspectional program.

Created by the International Medical Device Regulators Forum, MDSAP allows firms to undergo one audit by an accredited third party...

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