Senior expertise in medical device usability engineering
Usarea supports medical device manufacturers with their usability engineering process, from strategy to user evaluations, in line with IEC 62366-1, ISO 14971, MDR, IVDR and FDA Human Factors expectations.
I created Usarea to help teams build clear, proportionate and defensible processes, without turning usability engineering into a documentation nightmare.
With Usarea, you work directly with a senior usability engineering specialist, involved in the critical steps of your file: scoping, use-related risk analysis, protocol, evaluation, results analysis and regulatory conclusions.
A few key figures
Experience built across varied projects, demanding use contexts, and both European and US regulatory processes.
10+ years
of experience in medical device usability engineering
50+ manufacturers
supported throughout my career
2000+ user sessions
conducted or analyzed
CE · MDR · IVDR · FDA
processes tailored to European and US requirements
My background in medical device usability engineering
Passionate about the medical field for as long as I can remember, I have spent over 10 years helping medical device manufacturers understand, evaluate, and document real-world use.
Throughout my career, I have worked on a wide range of devices and use contexts: medical software, connected devices, hospital devices, home-use devices, implantable or interventional devices, medical imaging, in vitro diagnostics, ophthalmic products, dental devices, professional interfaces, instructions for use, training materials and use procedures.
I have supported usability engineering processes at different levels of maturity: strategic scoping, use specification, use-related risk analysis, formative evaluations, summative evaluations, legacy device (UOUP) files, FDA Human Factors validations, IEC 62366-1 training, and updates to existing files.
This hands-on experience shapes my approach: connecting what is observed with users, use-related risks, regulatory requirements, and the choices that need to be defended in the file.
My view on usability engineering
Usability engineering shouldn't be treated as a regulatory box to tick at the end of a project.
Done well, it's a process of design, risk control and evidence. It helps understand how users actually interact with a device, identify use difficulties, analyze their causes, and document the decisions made throughout development.
This is the logic I bring to Usarea: staying compliant without turning it into a documentation nightmare, and helping teams understand, justify and defend their usability engineering process.
My guiding principles
Every mission is built around the same requirement: applying the right level of rigor, producing usable deliverables, and enabling teams to defend their process.
Regulatory rigor
I help manufacturers connect the requirements of IEC 62366-1, ISO 14971, MDR, IVDR and FDA Human Factors, to build a process that is coherent across real-world use, use-related risks, user evaluations and file deliverables. Regulatory rigor isn't just about citing the right standards — it's about applying them to the real context of the device, its users and its environment of use.
Proportionality
Not every usability engineering process needs the same level of formalization. A formative evaluation, a summative evaluation, a file audit or a post-market analysis don't serve the same purpose. My role is to help teams apply the right level of rigor: solid enough to be defensible, pragmatic enough to stay useful to the project. The goal isn't to do more. The goal is to do it right.
Hands-on experience
Usability engineering isn't just about documents. It also relies on what actually happens during evaluations: unexpected behaviors, use errors, hesitations, workarounds, misunderstandings, training gaps or environment-related difficulties. My hands-on experience lets me analyze these situations with nuance, without minimizing or overdramatizing the results.
Defensibility
A good usability engineering deliverable must be clear, traceable, and detailed enough to be understood, reused and defended. Teams need to be able to explain why methodological choices were made, how users were selected, why scenarios are representative, what the results mean, and how conclusions connect back to use-related risks.
A specialized practice, a senior point of contact
Usarea is a practice specialized in medical device usability engineering.
Projects are carried directly by Amandine Broussier on the highest-value steps: scoping, evaluation strategy, use-related risk analysis, protocol, running or supervising sessions, analysis, interpretation of results and regulatory conclusions.
You know exactly who is working on your file, at what level of experience, and with what methodological logic. This direct involvement enables precise, responsive and consistent support, from the first scoping questions through to the deliverables included in the regulatory file.
With Usarea, senior expertise isn't only present at the scoping stage, it's applied throughout the steps that actually determine the quality of the file.
What you can expect from Usarea
Clear guidance
I take the time to explain the logic behind the process, the methodological choices, and the points to defend, so teams don't just have to live with their usability engineering file.
Usable deliverables
Deliverables are designed to be included in the regulatory file, but also to be understood by project teams: Regulatory Affairs, Quality, R&D, clinical, product or leadership.
An honest approach
User results should never be dressed up or over-interpreted. An error, a difficulty or an unexpected behavior needs to be analyzed, put in context, and connected to use-related risks before drawing conclusions.
Expertise directly applied
Senior expertise isn't only present at the commercial scoping stage. It's applied throughout the steps that actually determine the quality of the file: methodology, protocol, analysis, interpretation and conclusions.
A question or a project?
Looking to scope a usability engineering process, prepare a summative evaluation, audit an existing file, or train your teams on IEC 62366-1?
Let's discuss your projectA confidential, no-obligation conversation to understand your context and identify the right level of support.