Medical software development increasingly requires an approach that combines safety and cybersecurity throughout the entire product lifecycle. While IEC 62304 is the reference standard for the medical software lifecycle, IEC 81001-5-1 builds on this framework by introducing specific cybersecurity requirements for software development and maintenance.
The article explains how the two standards complement each other. IEC 62304 focuses on software lifecycle processes and functional safety, whereas IEC 81001-5-1 introduces concepts such as Secure Development Lifecycle, Threat Modeling, vulnerability management, and security updates to strengthen software resilience in real-world environments.
Together, the two standards redefine how medical software is designed, verified, and maintained, integrating both safety and security into a single risk management framework.
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