Diagnose
Usability Review
We check your usability engineering file against IEC 62366-1 and FDA human-factors guidance before you submit, and tell you exactly what to fix.
- Price
- From €6,000
- Length
- 4 weeks
- Step
- Diagnose
A lot of teams write the usability engineering file at the end of the project, once the design is already finished. That's when the gaps show up: critical tasks that were never tested, hazard-related scenarios that don't match the risk analysis, and instructions for use that nobody checked with real users. We read the file you already have, clause by clause, and give you a ranked list of what to fix before a notified body or the FDA asks about it.
Who it’s for
- Medical device and diagnostics teams preparing a submission
- Software as a medical device (SaMD) teams with a usability file in progress
Scope
What’s included, and what isn’t.
You get
- A clause-by-clause gap matrix against IEC 62366-1 and FDA human-factors guidance
- A review of your critical tasks and hazard-related use scenarios
- Checks for AI output and automation bias, where your product uses them
- A usability review of your instructions for use (IFU)
- A ranked fix list, with a recorded walkthrough of every finding
Not included
- Setting up a usability engineering process from scratch
- Writing or creating your usability engineering file
- Running formative or summative studies, or recruiting participants
- Regulatory consulting, submission, or sign-off
- Design or conformity decisions, which stay with the manufacturer
Don't have a usability engineering file yet? Building the process and the file is a larger engagement, and we scope and price it separately.
How it runs
What happens after you book.
- Week 1
We read your usability engineering file, your risk analysis, and your IFU, and agree on the questions you need answered.
- Week 2
We map the file clause by clause against IEC 62366-1 and the FDA human-factors guidance.
- Week 3
We review your critical tasks, your hazard-related use scenarios, and the IFU.
- Week 4
You get the gap matrix, the ranked fix list, and a recorded walkthrough of what we found.
What we need from you
- Your usability engineering file and risk management file
- Your IFU and labelling
- One person who can answer questions about the device
Not sure if you're ready? You can book a €1,000 two-hour triage first. It's credited against the full review if you book it within 14 days.
Related work
Projects where we did this kind of work.
Payment
From €6,000, fixed once we agree on the scope.
Projects under €5,000 are paid in full before work starts. For projects at €5,000 and above, you pay 50% at kickoff and 50% on delivery. Once we've agreed on the scope, the price is fixed.