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