Services Usarea
It isn't always clear whether you need a formative evaluation, a summative one, to complete an existing file, justify the absence of a study, or adapt a CE process to FDA expectations.
I help you scope the right usability engineering strategy, at the right time, with the right level of rigor.
The goal: avoid unnecessary processes, poorly scoped studies, and deliverables that are hard to defend.
Scope my processIn brief
Scoping the right process, prioritizing useful deliverables, and avoiding poorly sized actions.
You're torn between an audit, documented justification, formative or summative evaluation.
CE marking, FDA 510(k) submission, De Novo, a modification, or a file update.
Timeline, budget, expected level of evidence and internal constraints all need to align.
This support helps clarify the possible options and prioritize the actions that are actually useful.
I analyze your context: device type, users, environment of use, use-related risks, file maturity, evaluation history and regulatory objectives.
Based on these elements, I help you define a proportionate strategy: what must be produced, what can be justified, what deserves testing, and what can wait.
The point isn't to multiply deliverables, but to build a coherent, understandable and defensible process.
Strategic scoping note
Usability engineering action plan
Opinion on the need for a formative or summative evaluation
CE / FDA Human Factors strategy
Review of the impact of a modification
Decision support for RAQA, R&D or leadership teams
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.
01
Understanding the product, users, regulatory context and existing elements.
02
Building, auditing or completing the necessary elements based on need.
03
Providing usable deliverables and recommendations teams can understand.
Let's discuss your context and the options available.
Let's discuss your project