Clinical resources for

Medical Apps

With our all-in-one solution, we provide you with all clinical resources you need for the development and the usability file of medical apps

The challenge

The new Medical Device Regulation (MDR) raises the requirements for medical app developers. Increased usability testing is intended to prove user-friendliness and low risk in the application. A wide range of potential clinical end users for the app also means that there is a high demand for clinical experts for professional testing. These are difficult to integrate outside the clinical routine.

Our solution

We take care of the organization and implementation of the necessary usability studies and integrate a valid number of suitable clinical experts into your project. Evaluations are compiled according to IEC 62366 for your usability file. With our all-in-one solution you get additional access to clinical resources through our framework agreements with various clinics – all the clinical resources you need for an approval of your medical app.

Three benefits by working with M3i

What we can deliver through our platform with standardized processes
One-stop solution

Experienced clinical experts & realistic test environment. All evaluations are performed according to IEC 62366

Access to lead users

Present your solution to interested clinical end users in a legal and compliance conform environment

Digital Biobank

Legally compliant exchange of clinical relevant data for studies and integration of AI components

What clinical resources do you need for your project?

Working with M3i

Clinical evidence in three simple steps

1

Clarification of needs

Regulatory classification of the app and, based on this, clarification of required clinical resources for the approval of the software.
2

Implementing the study

Integration of lead users from clinical practice and clinical infrastructure. Structured execution and recording of the surveys/tests.
3

Results & evaluation

Recording of study results according to IEC 62366, suitable for your usability file. If necessary, compilation of recommended actions for your developers.