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Demonstrating cybersecurity compliance for your medical device.

July 5, 2024 gloizouUncategorized

There are published guidance documents including checklists on how medical device manufacturers can demonstrate cybersecurity compliance. Checking your devices against these guidelines can help you prepare your technical files for submission and auditing.

Tagged ARTG, Australia, Europe, IVDR 2017/746, MDR, MDSAP, sponsor, TFDA, TG MD Regs 2002, TGA

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MDCG revised document, MDCG 2022-4 Rev 2
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