Services Usarea
I support medical device manufacturers and pharmaceutical companies with their usability engineering, document audit, CE/FDA strategy and AMM readability/usability studies.
Depending on your project's maturity, the support can cover scoping the process, auditing an existing file, building usability engineering deliverables, organizing user tests, or conducting readability and usability studies for medicines.
The goal: a clear, proportionate and defensible approach, suited to the product, its users, its use-related risks and the applicable requirements.
Scoping the right process before taking action.
To define the necessary deliverables, prioritize useful actions, anticipate CE/FDA expectations, and avoid poorly scoped processes.
Discover strategic supportAssessing the compliance and robustness of an existing file.
Global IEC 62366-1 compliance audit, deliverable review, clause-by-clause analysis, compliance level, explanations and upgrade recommendations.
Discover IEC 62366-1 auditsBuilding and documenting a clear, defensible usability engineering process.
CE, MDR, IVDR and FDA Human Factors support: use specification, use-related risk analysis, formative and summative evaluations, 510(k), De Novo, protocols, reports and usability engineering file.
Discover CE & FDA supportAssessing the readability and usability of medicines.
Readability and usability studies for medicines, in line with Directive 2001/83/EC and EMA/ANSM recommendations.
Discover AMM studiesNot every team has the same resources, the same level of maturity, or the same timeline constraints. I can step in for punctual support, full project ownership, or a hybrid format, depending on your context.
You have an internal team, but want to secure your methodological choices and get an expert perspective at key stages.
I help you scope, challenge and prioritize.
You want to delegate a mission or an entire step: audit, protocol, user testing, analysis, report, usability engineering file, or AMM study.
I take charge of the expected deliverables, with a clear and documented methodology.
You already have internal resources, but need expert reinforcement on specific sensitive points: strategy, use-related risk analysis, methodology, interpreting results, or preparing the file.
I step in where senior expertise adds the most value.
Let's discuss your context, constraints and the right level of support.
Let's discuss your project