FAQ · Usability (IEC 62366-1)
Frequently asked questions
Find answers to the most common questions about IEC 62366-1, CE and FDA processes, file audits and how Usarea's support works.
What is usability engineering (IEC 62366-1)?
Usability engineering is the process that aims to enable the safe and effective use of a medical device by its intended users, in the intended environments and conditions of use. IEC 62366-1 covers, in particular, the analysis of users and environments, the identification of use-related risks, the development of the user interface, and formative and summative evaluations. This process is expected in CE marking files (MDR, IVDR) as well as in FDA Human Factors submissions, notably 510(k) and De Novo.
How long does a full usability engineering process take?
This depends directly on the complexity of the device, the number of user profiles involved and the project's level of maturity, so there is no universal duration. As a rough guide, strategic scoping can be carried out in a few weeks, while a complete process (use specification, use-related risk analysis, formative and summative evaluations, documentation) generally spans several months, in parallel with product development. The schedule is always built around your regulatory timeline and project objectives.
Can you guarantee that my file will be accepted by a notified body or the FDA?
No, and I would be wary of anyone who promised you that. The final decision rests with the notified body or the FDA and depends on many factors that go beyond usability alone. What I can commit to, however, is the clarity of the process, the traceability of the choices made, consistency with the applicable requirements, and the quality of the material produced to address any questions that arise.
How do you work when we already have an existing file to complete or audit?
I always start by analysing the existing file before proposing any support. It is never a matter of applying a standardised audit without taking the project's context into account. Depending on the needs identified, the engagement can take several forms: a clause-by-clause IEC 62366-1 compliance audit with prioritised recommendations, a critical review of a deliverable, targeted additions, or a broader rework of the process if the file's consistency requires it. The goal is always the same: identify what is solid, what can be improved and what is missing, without making you redo what is already sound.
Do the data and feedback from tested users remain confidential?
Yes. Information gathered during interviews, observations or user tests is treated as strictly confidential and used only within the scope of the engagement entrusted to me. Confidentiality agreements can naturally be put in place when needed. Personal data is processed in accordance with applicable regulations.
Do you work as a subcontractor for regulatory consulting firms?
Yes. I regularly work as a subcontractor for firms specialising in regulatory affairs, quality or medical devices, when they want to add usability expertise to their offering. In this type of collaboration, I integrate into the existing team and work within the methodology and schedule defined with the partner firm.
Why choose an independent consultant rather than a larger firm?
Because you know exactly who is working on your project, with what level of experience and what continuity of judgment. Every strategic step - scoping, use-related risk analysis, protocols, evaluations and documentation - is handled directly by me. In a larger organisation, the person you meet at the first appointment isn't always the one actually supporting the project day to day.
How many manufacturers have you worked with?
Over the course of my career, I have supported more than 50 manufacturers and conducted or analysed more than 2,000 user tests, on CE marking, FDA and MA projects. This experience covers a wide range of devices: medical software, implantable devices, medical imaging, in vitro diagnostics, connected devices, mobile applications and hospital equipment.
Do you work alone on each engagement, or with a team?
I directly own the steps that structure the process: scoping, strategy, use-related risk analysis, protocols, conducting or supervising tests, analysing results and writing the deliverables. Depending on the need, I may occasionally draw on specialised partners for recruitment, translation, simulation or logistics, while keeping methodological oversight.
What types of devices do you work on?
I work across all classes of medical devices (Class I to III under the MDR, Class A to D under the IVDR), as well as on medicines within the scope of readability and usability studies for MA applications. My experience notably covers medical software (SaMD), implantable devices, interventional devices, medical imaging, in vitro diagnostics, connected devices, remote monitoring solutions, and devices used in both hospital and home settings. If your device isn't explicitly listed here, feel free to reach out - the methodology adapts to the context of each project.
What happens during a first point of contact?
The first conversation is free of commitment. It's an opportunity to understand your device, your regulatory context, the project's progress and your objectives. Based on this, I suggest the most suitable level of support: strategy, audit, full support, training or a one-off engagement.
Do you offer one-off support if we already have an in-house team?
Yes. If you already have a Human Factors team or in-house expertise, I can step in on a one-off basis to bring an expert perspective on a specific issue. This might include a documentation audit, a critical review of a protocol, support on use-related risk analysis, assistance during user evaluations, or targeted input on certain deliverables. You keep control of your project; I step in where complementary expertise adds the most value.
Is a summative evaluation always necessary?
No. The need for a summative evaluation depends notably on the risks related to use, the changes made to the device, the data already available and the regulatory strategy chosen. A prior analysis helps determine whether a new evaluation is needed, under what conditions it should be conducted, and how to justify it to the relevant authorities.
Do you also work on FDA projects?
Yes. I support manufacturers in preparing their FDA Human Factors files, notably for 510(k) and De Novo submissions. Depending on the need, this support can cover Human Factors strategy, adapting a CE file to FDA expectations, preparing a validation study, drafting protocols and reports, and support during preparatory exchanges (Pre-Sub).
Do you only work in France?
No. I work with both French and international companies, and I can organise user evaluations in France or abroad, depending on the project's needs. Deliverables can be written in French or English, notably for files intended for an FDA submission.
Can you work on just one deliverable?
Yes. You don't necessarily need full support. I also take on targeted needs: auditing an existing file, reviewing a use specification, use-related risk analysis, an evaluation protocol, a report, Human Factors strategy, training, or a critical review of a deliverable before submission. The engagement is scaled to your actual needs, without imposing a full-scope service.