Medical device design agency
Fessburn is a product studio in Warsaw and Poznań. We design and test the software on medical devices and in clinical workflows, and we plan the IEC 62366-1 usability engineering file from the first workshop.
We've done this work for Bayer, Philips, QIAGEN, and ORtelligence. The usability evidence from the QIAGEN project went into a regulatory submission that passed.
A lot of teams write the usability engineering file once the design is already finished. That's when the gaps show up: critical tasks that were never tested, and hazard-related use scenarios that don't match the risk analysis.
We plan the file alongside the design instead. This way, the evidence is already there when a notified body or the FDA asks for it.
When you add a new parameter or an AI feature to a device that's already validated, you add new failure modes, even if most of the workflow stays the same. We separate the new tasks from the ones that were already validated, so the testing focuses on the new risk.
Medical devices
Philips needed a new parameter on its bedside monitors. We turned the requirements into 14+ use scenarios, five safety decisions, and uFMEA inputs. More than 200 possible use errors went into the uFMEA review, and about 20 participants took part in the formal usability study.
Diagnostics
We led risk-based UX and usability engineering for sample preparation and assay setup, and delivered five evidence outputs, a formative study plan, and a summative-readiness checklist. The evidence went into a regulatory submission that passed.
Critical care
We designed the clinician and investigator views for an ARDS risk-monitoring platform and ran moderated prototype testing across the whole workflow. Clinicians went from about 30 seconds to less than 5 seconds to spot a critical change, and the platform went into a pilot.
Operating room
We designed the mobile scanning flows surgical teams use to account for every instrument, including the confirmation and recovery states. Preparation became 75% faster, and overall operation time dropped by 40%.
If you're about to submit and you're not sure your usability engineering file is complete, we read it clause by clause against IEC 62366-1 and the FDA's human factors guidance. It takes 4 weeks and starts from €12,000.
The review doesn't include writing your file, running formative or summative studies, or regulatory sign-off. Design and conformity decisions stay with the manufacturer.
If you'd like to start smaller, you can book a €1,500 two-hour triage first. It's credited against the full review if you book that within 14 days.
| Rule | Date | What it covers |
|---|---|---|
| IEC 62366-1 and FDA human factors guidance | Applies now | The usability engineering standard notified bodies and the FDA expect for medical device software. |
| MDR transition for higher-risk devices | 31 Dec 2027 | Devices certified under the old directives have to move to MDR certificates. |
| MDR transition for lower-risk devices | 31 Dec 2028 | The later deadline for the remaining device classes. |
| AI Act rules for AI in medical devices | 2 Aug 2028 | AI built into medical devices takes on the AI Act's high-risk obligations. |
These dates are from our October 2026 research. Check them with your regulatory team, because this isn't regulatory advice.
The Usability Review doesn't include running studies or recruiting participants. On the QIAGEN project, we wrote the formative study plan and a summative-readiness checklist. If you need study work, we scope and price it separately.
Yes. Building the process and the file is a larger piece of work than the review, so we scope and price it separately.
Yes. The Usability Review is for medical device and diagnostics teams preparing a submission, and for SaMD teams with a usability file in progress.
Yes. If you need one before sharing files, send it with your first email to hello@fessburn.com.
Send us a short description of the device and where your usability engineering file is at. We'll reply with what we'd recommend, starting with the two-hour triage if that fits.