Bridging IEC 62304 and IEC 81001-5-1: Aligning Software and Cybersecurity Lifecycles in Medical Devices

Regulators around the world are reshaping how medical device software is designed, developed, and maintained, placing cybersecurity on equal footing with safety. This white paper explores how manufacturers can align IEC 62304 software safety processes with IEC 81001-5-1 cybersecurity requirements across the product lifecycle. Learn why late-stage security creates risk, how integrated or parallel lifecycles work in practice, and why traceability is essential for sustainable compliance.

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