The usability engineering file and the risk management file describe the same hazards from two directions. They drift apart one edit at a time, and traceability is the work of keeping them together.
A usability engineering file is the record required by IEC 62366-1 showing how a device’s user interface was designed and evaluated for safety: the use specification, user interface characteristics related to safety, known use problems, hazard-related use scenarios, the formative evaluations and the summative evaluation. ISO 14971 sets out the risk management process, and its risk management file holds the hazards, hazardous situations, risk controls and verification.
The two are meant to connect. A hazard-related use scenario in the usability file should appear as a hazardous situation in the risk file, its risk control should be a design or labelling change, and the summative evaluation should verify that control. In practice the files are kept by different people in different tools, and the links break.
Traceability is where AI earns its place: reading both files, proposing the links, and flagging every scenario without a risk entry, every control without verification and every formative finding that never reached the risk file.
IEC 62366-1 records
ISO 14971 records
scenario to hazard to control
or rejects with a reason
versioned with both files
unlinked or unverified
It is the collection of records IEC 62366-1 requires to show the usability engineering process was followed: the use specification, user interface characteristics related to safety, known use problems, hazard-related use scenarios, the user interface evaluation plan, formative evaluations and the summative evaluation. It can be a single document or a set of linked records, as long as it is traceable.
IEC 62366-1 applies the ISO 14971 risk management process to the user interface. Use-related hazards identified in usability work feed the risk analysis, risk controls often take the form of interface or labelling changes, and the summative evaluation verifies that those controls work. That two-way dependency is why the files need to stay traceable to each other.
It can support it: proposing hazards from similar devices and complaint data, checking traceability and finding gaps. It should not estimate risk or decide acceptability, which ISO 14971 places with the manufacturer’s risk management process and its criteria. We build the support layer and leave every risk judgement and signature with your engineers.
What we built, what stage it is at, and a link to the live thing wherever there is one.
yourOS is an operating system with an AI at its heart. You talk to it like a person, out loud or typed. It makes your calls, plans your days and works on your projects with a crew of agents, on your own private server. Our own product, built from the first commit; the waitlist is open.
Website, backend and app assets for Sonora, a free AI sound-therapy app on iOS and Android published by Cognitive AI.
Brand, website, prototype, apps on five platforms, the AI backend and the algorithm-intelligence pipeline for Podswap, a social growth engine that runs without a human in the loop.
In closed beta: Roxy, a private AI assistant with permanent memory running on infrastructure the user owns. Brand, site, product, backend and conversational design.
Live at coherence.com: brand identity generated with AI agents we directed, the motion system and website for the group behind Sonora, AboutAI, WakeUp and MudShadows. Agent work remains in build.
Live at domainbooth.com for DomainBooth, a premium domain brokerage: a new animated mark, every page redesigned and rebuilt with designed mobile layouts, and a custom CMS for its sales record, featured names, press and enquiries.
We start by running the trace check on one device’s usability and risk files and showing you the gaps.
30-minute technical call · no deck