Studies

Obtaining certification or a listing requires a variety of supporting evidence. We can help you to plan the evidence you will need and to carry out the necessary testing, as well as putting you in touch with experts in relevant fields.

Topics

Proof of Medical Benefit

In order to register therapeutic medical technical devices in the German Register of Medical Devices (Hilfsmittelverzeichnis – HMV), medical evidence must be provided against range of different criteria. The scope and content of the supporting evidence required can vary wildly between devices.

Our experts can organise and guide you through testing in a suitable environment, working together with qualified external reviewers.

Clinical Studies

Clinical evaluations must be carried out for all medical devices. Clinical data from studies is required in order to certify certain devices or to provide evidence regarding certain features. Planning and carrying out clinical studies requires specialist knowledge and reliable partners.

We can organise and oversee your studies, working together with suitably qualified clinical Institutes.

Positive Care Effect

As part of the German Federal Institute for Drugs and Medical Devices (BfArM)’s approval application procedure, all digital healthcare applications must show evidence of a positive care effect (positiver Versorgungseffekt). The scope and content of the supporting evidence required can vary significantly depending on the nature of the software concerned.

Our experts can organise and guide you through testing in a suitable environment, working together with qualified external reviewers.

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