Medical Devices meet the Cyber Resilience act

Your IECC 62304 compliance is a strong foundation, but the CRA brings new challenges.

want to explore your CRA readiness?

You're already ahead

If you're developing medical devices under IEC 62304, you've already built solid foundations. Your software lifecycle processes, requirements traceability, risk management frameworks, and design controls put you ahead of most industries facing the Cyber Resilience Act.

But the CRA introduces requirements that go beyond traditional medical device standards.

What's new under the CRA

The Cyber Resilience Act emphasizes four areas that extend beyond IEC 62304:

Software Bill of Materials (SBOM) needs to be machine-readable and continuously updated throughout your product's lifecycle, not just a one-time deliverable.
Vulnerability management requires systematic tracking of security issues in your components, with documented impact analysis and defined response timelines.
Component monitoring must continue throughout the entire product lifecycle, not just during initial development and validation.
Incident response processes need structured documentation that creates complete audit trails.

the traceability challenge

Here's where many medical device teams face difficulties. Your development environment likely includes separate systems for requirements management, risk analysis, source control, test management, and documentation. When an auditor or regulator asks for the complete trail of a specific component, from supplier evaluation through risk assessment to affected products and mitigation verification, you're piecing together information from multiple disconnected tools.

This takes time. More importantly, it creates compliance risk.

A Real-World Test
Imagine a security vulnerability is discovered in a third-party library your devices use. Can you quickly demonstrate how you evaluated that component, which risk assessments cover it, all products affected, your mitigation plan, and verification evidence?

If this requires hours of manual searching across systems, you've identified your gap.

Closing the Gap
Modern application lifecycle management approaches connect your development artifacts, automate component tracking, integrate vulnerability management, and maintain complete traceability. This transforms manual cross-system searches into structured workflows that support both development efficiency and regulatory compliance.

What you should do now

Start by mapping how information flows across your current tools. Identify where traceability breaks down and where manual effort is needed. Test your ability to respond to the scenario above. The earlier you address these gaps, the more prepared you'll be for CRA requirements.

Understanding how the CRA applies to your specific products requires expert guidance, but assessing your current readiness is something you can start today.