UsabilityPLUS 1

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.

Why Usability?

Effective, iterative and user-centered product development is essential to bring a safe and competitive product on the market. Early usability evaluations avoid unnecessary cost, effort and frustration for your company.

Why M3i?

M3i provides you with easy and fast access to medical professionals, objective data and a highly realistic environment for usability testing to minimize all risks. In addition, we are certified according to ISO 13485.

Selection of our Clients

Benefit from access to our broad network of hospitals and experts




clinical experts


different medical disciplines
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.




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

UsabilityPLUS 2
M3i Templates according to IEC 62366

Get started with our free Usability test protocol

Download hereDownload here
Let’s talk about this

Discuss your project with us and schedule a video call with our Usability Expert

Contact us
Verena Weigl

Verena Weigl

Senior Usability Consultant

What our clinical experts say about us



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 department

Brainlab 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 Manager


Discuss your project with us:
Benefit from our expertise for rapid and reliable proof of usability.