Usability testing for Medical devices
01
OUR MISSION
We help medical devices and IVDs manufacturers conduct usability tests in compliance with IEC 62366-1 and the MDR 2017/745 / IVDR 2017/746.
We deliver the insights and evidence you need to make confident product decisions and accelerate regulatory approvals (FDA and CE Marking).
02
WHAT WE DO
Different expertise to support you at every stage of your project.
01
Early-stage discovery & conception evaluation
Identify unmet needs, assess risk, and shape product vision through contextual inquiry, ethnography, journey mapping, and foundational research.
02
Formative usability testing
Optimize workflows, interfaces, and labeling by identifying use-related risks early in development.
03
Human factor validation (HFE/UE)
Conduct FDA- and 62366-1-aligned summative studies to demonstrate safe and effective use in preparation for FDA and/or Notified Body approval.
04
IFU, secondary packaging, & training effectiveness
Evaluate clarity, retention, and performance to support labeling claims and onboarding plans.
05
Post-market studies
Monitor usability in the field and identify improvements for next-gen versions.
6
Marketing claims & ecosystem design
Test the end-to-end experience, from app to device to training, to build claims and product roadmaps grounded in real user insight.
03
HOW WE WORK
Rigorous enough for your notified body. Responsive enough for your deadline.
01
Representative participants, recruited on schedule
Our panel of patients, caregivers and healthcare professionals across Europe and the US lets us recruit the exact user profiles your study requires. Each participant is screened against your user groups, and recruitment is planned over around three weeks to keep your timeline on track. Compensation and anti-gift compliance, including CNOM declaration, are handled for you.
02
Usability testing in real-world condition
We test your product in the environments in which it is used. Our research environments are designed to reflect real-world conditions:
-
Hospitals and long-term care facilities
-
Global in-home and outpatient settings
-
Simulated-use labs
-
Specialized simulated surgical suites
-
Remote and hybrid contexts
03
Risk-based protocols, submission-ready reports
Every study starts from your use-related risk analysis. We identify the critical tasks, build test scenarios around them, and size each user group according to IEC 62366-1 and FDA Human Factors guidance.
Our reports trace each finding back to the risks it addresses, so they integrate directly into your usability engineering file and hold up to notified body or FDA review.
04
One study design, two markets
Planning to launch in both Europe and the US? We design your study to meet CE and FDA expectations from the start, instead of adapting it afterwards.
Through our partnership with Bold Insight, a US human factors agency with FDA submission experience, we coordinate fieldwork on both sides of the Atlantic under a single, consistent methodology — avoiding duplicated studies and gaps in evidence.
04
WHY US?
Transatlantic partnership for CE and FDA studies
Through our formal partnership with Bold Insight, a US human factors agency specialised in FDA submissions, we run coordinated studies in Europe and the US under one methodology. One programme covers both markets, without running your study twice.
Regulatory fluency, built into every deliverable
IEC 62366-1, ISO 14971, FDA Human Factors guidance, MDR and IVDR are the frameworks we work in daily. Protocols, critical-task analyses and reports are structured to what notified bodies and FDA reviewers expect to see, and integrate directly into your technical file.
The Strategist
Aug 2035
Leading universities collaborate with top tech companies on Autonomous Spacecraft Research.
ADIS journal
Jun 2035
CEO of Orbits Technologies Speaks at International Aerospace Conference.
Transatlantic partnership for CE and FDA studies
Through our formal partnership with Bold Insight, a US human factors agency specialised in FDA submissions, we run coordinated studies in Europe and the US under one methodology. One programme covers both markets, without running your study twice.
Regulatory fluency, built into every deliverable
IEC 62366-1, ISO 14971, FDA Human Factors guidance, MDR and IVDR are the frameworks we work in daily. Protocols, critical-task analyses and reports are structured to what notified bodies and FDA reviewers expect to see, and integrate directly into your technical file.
The Strategist
Aug 2035
Leading universities collaborate with top tech companies on Autonomous Spacecraft Research.
ADIS journal
Jun 2035
CEO of Orbits Technologies Speaks at International Aerospace Conference.
04
WHY US
Transatlantic partnership for CE and FDA studies
Through our formal partnership with Bold Insight, a US human factors agency specialised in FDA submissions, we run coordinated studies in Europe and the US under one methodology. One programme covers both markets, without running your study twice.
Regulatory fluency, built into every deliverable
IEC 62366-1, ISO 14971, FDA Human Factors guidance, MDR and IVDR are the frameworks we work in daily. Protocols, critical-task analyses and reports are structured to what notified bodies and FDA reviewers expect to see, and integrate directly into your technical file.
The Strategist
Aug 2035
Leading universities collaborate with top tech companies on Autonomous Spacecraft Research.
ADIS journal
Jun 2035
CEO of Orbits Technologies Speaks at International Aerospace Conference.
Direct access to the people running your study
No account managers, no hand-offs. The senior human factors specialist who scopes your study also designs and moderates it. That means fast answers and quick turnaround, without cutting corners on sample size or critical-task coverage.
Hands-on experience across therapeutic areas
Injection pens, glucose meters and CGM sensors, implantable cardiac devices, IVD analysers and diagnostic kits: we understand the users, environments and risks specific to your device category.
The Strategist
Aug 2035
Leading universities collaborate with top tech companies on Autonomous Spacecraft Research.
ADIS journal
Jun 2035
CEO of Orbits Technologies Speaks at International Aerospace Conference.
05
TALK TO US
Let's talk about your project !