UsabilityPLUS 1

Usability Plus

IEC 62366-1 and FDA compliant evaluation as a factor for success in the development and approval of medical devices

Our services

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

35

clinics

400

clinical experts

15

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
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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.
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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

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

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Verena Weigl

Verena Weigl

Senior Usability Consultant

What our clinical experts say about us

“I appreciate my advisory role for M3i projects. The insight into these innovative projects is extremely important for me as a clinical end user.”

Prof. Dr. Joachim DissemondSpecialist in Dermatology and Venerology,

University Hospital Essen

“I am very happy to make my contribution to the development of innovative medical products. M3i enables a fair compensation.”

Katharina PlundkeSurgical nurse,

Hospital of the University of Munich

“The testing was very efficient and with minimal effort. It was managed very professionally by M3i.”

PD Dr. med. Ehab ShibanSenior Physician at the Neurosurgical Clinic,

University Hospital Augsburg

“I enjoy being able to contribute specific expertise to current projects.”

PD Dr. Cornelia Erfurt-BergeSenior Physician Department of Dermatology,

University Hospital Erlangen

“Through M3i as organizer I can estimate time and effort and know what I'm getting into.”

Nicole BettinSurgical Assistant,

Hospital of the University of Munich

“The possibility of influencing product development and adapting it to medical needs inspires me.”

PD Dr. Patrick LugenbielSenior Physician Cardiology, Angiology, Pneumology,

Heidelberg University Hospital

“Since the tests take place directly at the hospital and the process of evaluation by M3i is standardized and structured, I am always happy to participate.”

Dorian AndradeAssistant physician,

Hospital of the University of Munich

“M3i makes testing possible besides the clinical routine, since legal and financial matters are always compliant with our legal department.”

Prof. Dr. Wolfgang BöckerDirector of Clinic for General, Trauma and Reconstructive Surgery,

Hospital of the University of Munich

“With M3i I have the possibility to develop sustainable solutions for current problems in the treatment of patients.”

Prof. Dr. med. Dr. h.c. mult. Konrad KarczHead of Minimally Invasive Surgery,

Hospital of the University of Munich

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 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

EIZO GmbH

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

Contact us