Services Usarea
I support medical device manufacturers in building, documenting and justifying their usability engineering processes, in line with IEC 62366-1, ISO 14971, ISO 11607, MDR, IVDR and FDA Human Factors expectations.
This support can be part of a CE marking file, an FDA 510(k) submission, a De Novo pathway, a device modification, or an update to an existing file.
The goal: a clear, proportionate and defensible process, grounded in real-world use, use-related risks and applicable requirements.
In brief
IEC 62366-1 · MDR · IVDR · FDA Human Factors · 510(k) · De Novo
Define the deliverables required under IEC 62366-1, and build or complete a usability engineering file.
CE marking, FDA 510(k) submission, De Novo pathway, or adapting a CE process to FDA Human Factors expectations.
Connect use, use-related risks and user evaluations, or justify a change to an interface, instructions for use, or use procedure.
This support connects real-world use, use-related risks and regulatory requirements into a coherent, defensible process.
I work across the key steps of the usability engineering process: scoping, use specification, use-related risk analysis, evaluation strategy, protocol, evaluation, user testing, results analysis, reports and file deliverables.
With Usarea, methodological choices are made explicit, results are put in context, and deliverables are built to be understood, reused and defended by teams.
The point isn't just to run a user test or produce a report — it's to understand real-world use and document what the file actually needs.
Scoping the usability engineering process
Use specification
Use-related risk analysis
User interface evaluation plan
Formative evaluation protocol
Summative evaluation protocol
User testing
Analysis of performance, difficulties and use errors
Formative and summative evaluation report
Decision-oriented summary
CE / FDA Human Factors adaptation
Support for 510(k) or De Novo pre-sub submissions
Updating or consolidating an existing file
Possible components of a process, not fixed mandatory steps.
Intended use, users, environment, CE/FDA context.
Use-related risks, critical tasks, representative scenarios.
Formative, summative, user testing, Human Factors validation.
Protocol, report, usability engineering file, summary.
01
Understanding the product, users, regulatory context and existing elements.
02
Building, auditing or completing the necessary elements based on need.
03
Providing usable deliverables and recommendations teams can understand.
Let's discuss your device, your file and your CE/FDA constraints.
Let's discuss your process