CE & FDA usability for medical devices

I support medical device manufacturers in designing, conducting and justifying their usability processes, in line with IEC 62366-1, ISO 14971, ISO 11607, the MDR (EU 2017/745), the IVDR (EU 2017/746) and FDA Human Factors expectations.

This support can be part of a CE marking file, an FDA 510(k) submission, a De Novo procedure, a device modification, or an update to an existing file.

The goal: structure a process that is clear, proportionate and defensible, grounded in real-world use, use-related risks and the applicable requirements.

Let's discuss your process See IEC 62366-1 audits

IEC 62366-1 · MDR (EU 2017/745) · IVDR (EU 2017/746) · FDA Human Factors · 510(k) · De Novo

WHO IT'S FOR

This is for you if…

You need to build or complete your file

Define the deliverables required under IEC 62366-1 and build or complete a usability file.

You're preparing a regulatory milestone

CE marking, FDA 510(k) submission, De Novo procedure, or adapting a CE process to FDA Human Factors expectations.

You need to justify or document

Connect use, use-related risks and user evaluations, or justify a change to an interface, a package leaflet or a use procedure.

This support helps connect real-world use, use-related risks and regulatory requirements into a coherent, defensible process.

WHAT I BRING

Stepping in at the right level, from a targeted need to a full process

The support can cover a targeted step or several components of the process: scoping, use specification, use-related risk analysis, evaluation strategy, protocols, user tests, results analysis, reports and other file deliverables.

Methodological choices are made explicit, results are put in context, and deliverables are designed to be understood and reused by teams.

The challenge is stepping in at the right level: neither reducing the process to a single user test, nor imposing a full-scale process when a targeted need would suffice.

The components of a process tailored to your needs

These components can be used separately or combined, depending on your file, your risks and your regulatory objective.

Scope

Intended use, users, environment, CE/FDA context.

Scoping the usability processUse specification

Connect to risks

Use-related risks, critical tasks, representative scenarios.

Use-related risk analysisUser interface evaluation plan

Evaluate

Formative, summative, user tests, Human Factors validation.

Formative evaluation protocolSummative evaluation protocolUser testsEvaluationAnalysis of performance, difficulties and use errors

Document

Protocols, reports, usability file deliverables and decision summary.

Formative and summative evaluation reportsCE / FDA Human Factors adaptationFDA Human Factors support for Pre-Sub, IRB, 510(k) or De NovoUpdating or consolidating an existing file

METHOD

A clear method adapted to your project's level of maturity

Scoping

Understand the product, the users, the regulatory context and what already exists.

Production or analysis

Build, audit or complete the necessary elements based on the need.

Handover

Provide usable deliverables and recommendations that teams can understand.

Do you need to structure, complete or consolidate your usability process?

Let's discuss your device, your file and your CE/FDA constraints.

Let's discuss your process

CE and FDA experience · 510(k) · De Novo · tests in France and internationally