UsabilityPLUS M3i

Usability as a factor for success in innovation and approval

By providing all necessary clinical components for user-driven development and usability evaluation, we support medical device manufacturers and marketers in the innovation process and approval.


Next Level Usability: One contract – Everything you need

Best usability, high practical relevance, efficient approval and a fast market access – To achieve these goals we offer clinical expert panels, realistic test environment and test setup for idea workshops, formative, summative evaluations, benchmarking, publications or for marketing purposes.

Our service

Get access to:




clinical experts


different medical disciplines

What our clinical experts say about us

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

Our services

For best usability,

successful market access

and shorter time-to-market

Formative testing

Idea workshops, expert interviews and early testing to exploit potentials.

Summative testing

MDR-compliant organization, implementation and evaluation. Access to one of the most modern simulation centers in Europe.


Comparison with competing products in clinical use. Emphasis on market leadership.

Scientific publication

Scientific publications by KOL’s about your products.

Testing and creating the Usability Engineering File (UEF)

Use Specification, Use Scenario Specification and User Interface Specification


Measurable and reproducible claims & video content from usability evaluation for profound marketing.


What our customers

“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

Special aspects of UsabilityPLUS

Efficient integration of clinical components in development, approval and marketing with a single contract

All clinical components for development, approval (proof of usability) and marketing through a single contract with us. 

Broad network of experts & hospitals

Efficient integration of clinical experts (doctors, nurses, cleaning staff, IT administrators, patients, etc.) suitable for your project.

Realistic test environment

Realistic testing in one of the most modern simulation operating rooms in Europe.


All final reports matching your usability file. 

Get started: Our usability strategy consulting

MDR-compliant proof of usability for new or existing products can be an enormous challenge. Discuss your project with us and benefit from the experience we have gained in a large number of projects.

Why you should talk to us

Benefit from proven processes for rapid and reliable proof of usability.

What to expect

- As-is analysis
- Proven best-practice-tips
- Process optimization for efficient success

Current White Paper

White paperWhite Paper
October 6, 2021

Best practice example for MDR-compliant usability evaluation:
User study to verify a video management system of EIZO GmbH.

How can a successful MDR compliant formative usability evaluation in medical technology be practically designed along the development process? As part of a study conducted by EIZO GmbH in collaboration…
View blogpost

Our partners

We are certified:

UsabilityPLUS - ALT 1