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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

Executive Summary

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.

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