IEC 62366-1 makes sure your device can be used safely by the people who will actually use it, under the conditions they will actually meet. We help you build a usability engineering process that is rigorous, realistic and audit-ready.
IEC 62366-1 specifies a usability engineering process that identifies use-related risks, designs to control them, and validates that the device can be used safely by the intended users in the intended environment.
Incorrect use is one of the most common causes of medical device incidents. Regulators have shifted their expectations: usability evidence is no longer optional. FDA, MDR and TGA all expect a structured usability file.
From early use specification to summative validation, we help you build usability evidence that holds up in audit and submission.
Define your intended users, environments and use scenarios, the foundation for everything that follows.
Identify use errors and hazardous use scenarios. Integrate with ISO 14971 so you do not duplicate effort.
Iterative usability testing during design. Find problems while they are still cheap to fix.
Validate the final user interface with representative users in realistic conditions. We design the protocol and analyse the results.
We build or review your UEF so it tells a clear, defensible story from use specification to validation.
For the U.S. market we map your IEC 62366-1 evidence onto FDA’s Human Factors guidance, including the HFE/UE report.
FAQ
Yes. Software-only medical devices have a user interface and are subject to use-related risks. The principles of IEC 62366-1 apply, even though some artefacts will look different from a physical device. Usability engineering under IEC 62366-1 is risk-driven. Standard UX asks: is this delightful? Usability engineering asks: can this be used safely by the intended users in the intended environment without causing harm? If your risk analysis identifies use-related hazardous situations with serious harm potential (which it almost always does for medical devices), then yes. The number of participants and the rigour scale with risk. FDA has its own Human Factors guidance and expects an HFE/UE report. IEC 62366-1 covers most of what FDA wants, but the structure of the deliverable differs. We help you build one evidence base that serves both. IEC 62366-1 includes a process for evaluating user interfaces of unknown provenance, similar in spirit to SOUP in software. Legacy devices being placed on the market today still need a defensible usability file.