OUR SERVICES - USABILITY ENGINEERING & ERGONOMICS
Our services
From audit to summative evaluation, we support you at every step of the usability engineering process for your medical device.
Usability engineering
We support you through the usability engineering process (IEC 62366) for your medical devices, for MDR (EU 2017/745), IVDR (2017/746) certification or FDA clearance. We help you prevent errors, secure the user experience and strengthen your CE/FDA file.
- Audit & strategy
- Use specification
- Use risk analysisLiterature review, FMEA - ISO 14971...
- Clinical trial follow-up
- Interface specification
- Formative evaluationformative tests, interviews, focus groups, heuristic analysis...
- Summative evaluationsummative tests, root cause analysis...
- Usability Engineering Report (UER) compilation
- Post-production follow-up
- UOUP processAnnex C - 62366-1
Choose the personalised support that fits your needs
Coaching
You have an internal team but want expert support at every stage?
You do it, we guide you.
Ideal if…
…you want to build skills while meeting regulatory requirements.
Ideal if…
…you want to build skills while meeting regulatory requirements.
Full service
You need a reliable partner to handle one or all stages of your project?
We take care of everything.
Ideal if…
…you want to outsource parts of the project and save time.
Ideal if…
…you want to outsource parts of the project and save time.
Tailored
We handle certain key stages and support you on others.
A hybrid and flexible format.
Ideal if…
…you have resources but need occasional or strategic reinforcement.
Ideal if…
…you have resources but need occasional or strategic reinforcement.