No Cyber, No Sales: Regulatory Demands in Medical Device Development

Cybersecurity is now a regulatory requirement, not a competitive advantage. For medical device manufacturers, meeting the demands of the FDA and EU MDR means embedding security into every stage of development. 

Cybersecurity is reshaping the development lifecycle of medical devices, pushing traditional models like the V-Model to evolve to meet today’s expectations. Threat modelling, Software Composition Analysis (SCA), static code analysis, and penetration testing must now be embedded into IEC 62304-compliant development workflows. Compliance with Standards such as IEC 81001-5-1 and IEC 60601-4-5 is increasingly expected, along with the generation of artefacts such as the Software Bill of Materials (SBOM) and FDA-required cybersecurity documentation views. Beyond development, regulatory expectations now include updateability, incident response planning, and post-market surveillance—making these activities essential not only for approval, but for long-term product viability in a security-driven market. 

Security must be built in, not bolted on. Cybersecurity controls must be treated as system requirements, validated through the same V-Model lifecycle as any other functional feature. But unlike traditional requirements, these controls often originate from threat models—not client specs—making cybersecurity testing a distinct and critical phase. This isn’t just about passing audits, it’s about building trust in devices that operate in increasingly hostile digital environments. Without a clear cybersecurity strategy, manufacturers risk losing access to major markets. 

The Non-Negotiable Reality: No Cyber, No Sales

To understand how cybersecurity is becoming a gatekeeper for medical device innovation and how Critical Software helps teams navigate this shift, check our latest free whitepaper.