Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of technical skill. Designing for safety isn’t just good practice—it’s a regulatory and ethical imperative.
In our recent webinar, Designing for Safety: How to Build Safer, More Usable Medical Devices, hosted by Rook Quality Systems with guest speaker Ben Higgitt from Cognition Corporation, we explored how integrating risk management and usability engineering early in the development process can improve safety, compliance, and user experience.
The discussion covered the importance of approaching safety from day one, especially as devices are used in a wider range of environments by less experienced users.
We also examined the regulatory frameworks that guide this work, including ISO 14971, IEC 62366, FDA’s 21 CFR Part 820, EU MDR and IVDR, and the upcoming QMSR harmonization with ISO 13485. Speakers shared how usability engineering—identifying and mitigating potential use errors—intersects with risk management to create a more holistic safety strategy. Real-world examples demonstrated how design improvements can reduce hazards, and common regulatory submission deficiencies were reviewed to help teams avoid pitfalls.
Key Takeaways
- Usability engineering is not optional—it’s central to ensuring device safety.
- Regulatory expectations differ across markets, and your documentation approach must reflect that.
- Most “use errors” stem from perception and cognition issues—good design anticipates and mitigates these risks.
- Integrated, software-supported workflows improve traceability, accuracy, and collaboration across teams.
Watch the Webinar On Demand
Whether you’re designing your first device or refining a mature product, this webinar will give you practical insights and tools to make your devices safer and more usable—while meeting the latest regulatory requirements.
