
Usability Plus
IEC 62366-1 and FDA compliant evaluation as a factor for success in the development and approval of medical devices
We know your challenges
Getting a medical product approved is nearly impossible without good usability. Not having a realistic group of test users, not choosing the right testing scenarios or an unrealistic testing environment all form risks for not following conformity assessment procedures.
Selection of our Clients
Benefit from access to our broad network of hospitals and experts
35
400
15
Our Guidance
Usability Advisory
- MDR regulatory consulting on a specific part of your project
- Further education on usability through tailored workshops
- Individual project guidance by our Usability Expert
Our Services
Usability Solutions
- A complete solution to your usability problem
- Tailored to the needs of your project or company
- Efficient engagement of clinical experts:
Physicians, nurses, IT administrators, patients etc.
Our services
For best usability,
successful market access
and shorter time-to-market
Usability Engineering File
Includes Use Specification, Use Scenario Specification and User Interface Specification.
Use Context Analysis
Idea workshops, expert interviews and focus groups to exploit potentials.
Formative Testing
Early testing during product development for detection of use errors.
SUMMATIVE TESTING
MDR-compliant organisation, implementation and evaluation. Access to one of the most modern simulation centers in Europe.
We are certified:
Benefit from proven processes for your conformity assessment

M3i Templates according to IEC 62366
Get started with our free Usability test protocol
Let’s talk about this
Discuss your project with us and schedule a video call with our Usability Expert

Verena Weigl
What our clinical experts say about us
OUR
PARTNERS:
What our customers say about us
“With M3i, we can access a broad network of clinical experts in a short time and with low organizational overhead. We plan to further expand our collaboration in the future.”
Dr. Jörg UhdeHead of the spinal development departmentBrainlab AG
“By working with M3i, we were able to involve a large and diversified number of clinical experts in the product development phase.”
James BergeProduct ManagerEIZO GmbH