Services/Strategy
USABILITY STRATEGY
You're not sure whether to launch a formative evaluation, prepare a summative one, complete an existing file, justify the absence of a study, or adapt a CE process to FDA expectations.
I help you define a usability strategy suited to the device, the risks, the target market and the file's current progress.
The goal: avoid unnecessary processes, poorly scoped studies and deliverables that are hard to defend.
To scope the right process, prioritise the useful deliverables, and avoid poorly scoped actions.
WHO IT'S FOR
You're torn between an audit, documentary justification, a formative or a summative evaluation.
CE marking, FDA 510(k) submission, De Novo, or a file modification or update.
Timeline, budget, expected level of evidence and internal constraints need to be aligned.
This support helps clarify the options available and prioritise the actions that truly matter.
STRATEGIC SCOPING
I analyse your context: type of device, users, use environment, use-related risks, file maturity, evaluation history and regulatory objectives.
Based on this, I help you define a proportionate strategy: what needs to be produced, what can be justified, what's worth testing, and what can wait.
The goal isn't to multiply deliverables, but to build a process that is coherent, understandable and defensible.
What can be included
01
Device, users, risks, target market, file history.
02
Identify what needs to be tested, justified, audited or completed.
03
Build a realistic, defensible action plan.
Let's discuss your context and the options available.
Scope your process10+ years of experience · 50+ manufacturers supported · CE and FDA processes