The usability engineering process step by step
IEC 62366-1:2015 + AMD1:2020 · Usability engineering process
The short answer
The usability engineering process per 62366-1 runs from the use specification, through identifying hazard-related use scenarios and the user interface specification, to UI design, formative evaluation (iterative, during development) and summative evaluation (validation at the end). The central outputs are the use specification, the user interface specification and the usability engineering file.
The process steps
- Use specification: define user groups, use environment and intended use
- Identify hazard-related use scenarios: where can use errors lead to harm
- User interface specification: define the requirements for the operator interface
- UI design and implementation: design and build the interface
- Formative evaluation: test iteratively during development, find problems early
- Summative evaluation: objectively demonstrate at the end that the device can be operated safely
The central outputs
| Output | Content |
|---|---|
| Use specification | User groups, use environment, intended use |
| User interface specification | Requirements for the operator interface, including safety-related aspects |
| Usability engineering file | Overall evidence: specifications, scenarios, evaluation results, rationales |
Link to risk management
Hazard-related use scenarios are the bridge to ISO 14971: identified use errors are carried into the risk file as hazard sources and linked to risk controls. medairon helps you document this traceability from scenario to risk control in an auditable way.
Frequently asked questions
Do I have to document every step?
Yes — the usability engineering file should make the full process traceable. Auditors expect a continuous trail from the use specification to summative evaluation.
When do I start usability engineering?
As early as possible. Formative evaluation only works if it can still influence the design — usability engineering is an accompanying process, not a final test.