IEC 62366-1
The usability-engineering standard requires evaluation with real users. (EN IEC 62366-1 is not MDR-harmonised — state-of-the-art support only, no presumption of conformity.)
Medflow Simulator surfaces likely use errors before you build — and tells you where to point your real user test. It narrows where to look; it never replaces looking.
By then the architecture is frozen and the design inputs are locked — so the fix is unaffordable, and the use error ships. The earliest you can currently act is after you already have something to test. Simulator moves the first signal earlier, while the design can still change.
Run any of them, in any order. What you can honestly run depends on what you're evaluating.
Find where use errors are likely — before anything is built. Output is a concentration map: where errors cluster, so you know where to aim.
Pre-validation triageReal, representative users work through the tasks so you can find and fix problems while the design can still change. Diagnostic and iterative.
● Real usersHF validation on the frozen design — because for software, the screen is the product. Hardware and drug-device summative are not offered.
● Software onlyA simulation is pre-validation triage. It shows where errors are likely to cluster; it doesn't prove anything, and it doesn't replace IEC 62366-1 evaluation. It narrows where to look — it never replaces looking.
Bring a Figma or a plain description of the device and its steps — no account, no onboarding. Synthetic users run your tasks and hand back a concentration map of where errors are likely to cluster. You describe a design, not patient data.
An adrenaline autoinjector, used outdoors by a panicking bystander. They hear the actuation click, read it as “done,” and pull the injector at three seconds of a ten-second hold — delivering a partial dose while believing they saved a life. It's the best-documented use error in the class — and Simulator surfaced it from a declarative spec, before anything was manufactured.
The usability-engineering standard requires evaluation with real users. (EN IEC 62366-1 is not MDR-harmonised — state-of-the-art support only, no presumption of conformity.)
Finalised 29 May 2026 — organises submissions around critical tasks; eSTAR prompts for the HF submission category from 1 Aug 2026.
Risk management needs hazard → sequence of events → harm. The sequence column is the one everyone fudges; Simulator populates it with recorded evidence.
Integral drug-device combinations need a Notified Body Opinion whose scope includes usability. As of 2024, fewer than half of responding notified bodies had ever issued one.
The obviously-sellable features — photoreal environments, headline error percentages, “AI validation” — were left out on purpose. A false claim here is existential; restraint is the point.
Simulate → improve → validate. Software can go all the way to real, remote validation on screen, because for software the screen is the product.
Consented, de-identified outcomes from real studies sharpen the population targeting over time: better aim — never a rate to quote.
Not a replacement for IEC 62366-1 usability evaluation. It narrows where to look; it doesn't replace looking.
Not grounds to skip HF validation testing. It tells you where to focus that testing — it isn't a substitute for it.
No hardware or drug-device summative. Validation needs the physical device in hand — no screen reproduces force, feel, or the hold.
No “AI validation,” no headline error percentages, no photoreal “evidence.” Relative, conditional targeting signals only.
Bring a design; get a finding. Request early access to Medflow Simulator.
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