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AdvaMed To FDA: Add 3rd-Party Servicers, Refurbishers To Quality Management System Reg

The medtech lobbying group says it’s worried that such entities could be the target of cyberattacks

 
• By Shawn M. Schmitt

In comments to the US FDA on its proposed QMSR rule, AdvaMed says it’s concerned that third-party entities could fall prey to hackers because of the “current geopolitical environment that is fraught with cybersecurity threats.” In its own comments, the Association of Medical Device Service Organizations says the agency should remain hands-off.

Third-party concept image.
• Source: Shutterstock

Medtech’s largest lobbying group is putting the heat on the US Food and Drug Administration to include third-party servicers and refurbishers under the umbrella of its forthcoming Quality Management System Regulation (QMSR), which is currently in its draft phase.

The QMSR – a result of the FDA’s years-long work harmonizing the current Quality System Regulation with international quality systems standard ISO 13485:2016 – will, when finalized, replace the decades-old...

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