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
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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The second of two parts: Industry experts Vincent Cafiso, Kim Trautman and Dennis Gucciardo spoke with Medtech Insight about noteworthy comments on the US FDA’s proposed Quality Management System Regulation.
Longtime industry experts Kim Trautman, Steve Niedelman and Dennis Gucciardo spoke with Medtech Insight about interesting or insightful stakeholder comments on the US FDA’s proposed Quality Management System Regulation. Part one of two.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.