Strategy, audit and CE & FDA usability

I support medical device manufacturers and pharmaceutical companies at four key moments: scoping a process, auditing an existing file, running a CE/FDA usability process, or conducting an MA readability and usability study.

The engagement can be a one-off, a full service, or a hybrid, depending on what's already available, your internal resources and the project's level of maturity.

CE & FDA Usability

Design, conduct and document a clear, defensible usability process.

CE support, MDR (EU 2017/745), IVDR (EU 2017/746) and FDA Human Factors: use specification, use-related risk analysis, formative and summative evaluations, protocols, reports and file deliverables, notably for 510(k) and De Novo submissions.

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Strategy

Scope the right approach before taking action.

To define the necessary deliverables, prioritise useful actions, anticipate CE/FDA expectations and avoid poorly scoped processes.

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IEC 62366-1 Audit

Assess the compliance and robustness of an existing file.

Global IEC 62366-1 compliance audit, review of deliverables, clause-by-clause analysis, compliance level, associated explanations and upgrade recommendations.

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MA Studies - Readability & usability

Assess the readability and usability of medicines.

Readability and usability studies for medicines, in line with Directive 2001/83/EC and EMA/ANSM recommendations.

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ENGAGEMENT FORMATS

Three engagement formats based on your internal resources

You can keep full control of your file, delegate an entire mission, or split the tasks. The format is defined based on your in-house skills, your timeline and what's already available.

Advisory & oversight

You have an in-house team and want to challenge your methodological choices or get support on sensitive steps.

I help you scope, challenge and prioritise.

Ideal if…

…you want to build internal skills, keep control of your file and validate the critical points of your process.

Full delivery

You want to delegate an entire mission or step: audit, protocol, user tests, analysis, report, usability file or MA study.

I take charge of the expected deliverables, with a clear, documented methodology.

Ideal if…

…you're short on time, internal resources or specific usability expertise.

Hybrid format

You already have internal resources but need expert reinforcement on certain sensitive points: strategy, use-related risk analysis, methodology, results interpretation or file preparation.

I step in where an experienced perspective adds the most value.

Ideal if…

…you want to split the tasks while reinforcing the most critical steps.

Not sure yet which support fits your situation?

Let's talk about your context, your constraints and the right level of support.

Let's discuss your project