Meeting Regulatory Demands in Medical Device Development

As medical devices become increasingly connected, cybersecurity isn’t just a technical concern... it’s a regulatory imperative!

But how can manufacturers meet strict requirements from the FDA, EU MDR, and other global bodies, without compromising on innovation or time to market?

In this white paper, you’ll learn how Critical Software applies its expertise in safety-critical development to help medtech companies embed cybersecurity throughout the product lifecycle, and secure market access in the US, Europe, and beyond.

You’ll also discover:

• Why regulators are making cybersecurity a non-negotiable requirement for medical device approval
• How threat modelling, secure coding, and vulnerability management fit into the V-Model
• The key standards that govern medical device cybersecurity (like IEC 81001-5-1 and IEC 62304)
• How to ensure post-market surveillance, updateability, and incident response readiness
• What it takes to build a cybersecure medical device—from design to deployment