Ensure your medical devices are designed with the user at the centre with this comprehensive Human Factors Usability Procedure. Built on the internationally recognised frameworks of IEC 62366-1 and FDA Guidance FDA-2011-D-0469, this procedure provides a structured, lifecycle-spanning approach to integrating human factors and usability engineering into your medical device development process.

Rather than imposing a rigid, one-size-fits-all methodology, this procedure is intentionally designed to be adaptable. It acknowledges that medical devices differ significantly in complexity, risk profile, intended use environments, and user populations — and it empowers each project team to determine the appropriate scope and depth of human factors activities required for their specific device. Those decisions are then captured formally within a human factors plan, ensuring traceability and accountability without sacrificing flexibility.

The procedure applies to all device development projects that have undergone formal project initiation, covering the full spectrum of risk classifications — from Class I devices with minimal user interface complexity through to Class III and Class IV devices requiring extensive human factors validation studies. It addresses human factors considerations at every stage of the device lifecycle: initial conceptual design, detailed development, clinical evaluation, post-market surveillance, and any subsequent device modifications that could impact how users interact with the device.

By embedding systematic consideration of user needs, capabilities, and limitations throughout development, this procedure helps reduce use-related risk, supports regulatory submissions with confidence, and ultimately contributes to safer outcomes for patients and healthcare professionals alike. Whether you are bringing a first-in-class device to market or updating an established product, this procedure gives your team the framework to navigate human factors requirements with clarity and rigour.

Comes with a FREE training effectiveness evaluation assessment!