Health Technology Assessment

A substantial part of the applications according to § 137e and § 137h SGB V consists of an evidence-based assessment of the benefits of the new method. This can also be done as part of an independent health technology assessment for international use.

For this we create:

Systematic literature and study research

Assessment of the available evidence

Compared to established procedures

Compared to other competing processes

English version for use in other markets

Evidence from clinical trials

The Medical Device Regulation (EU 2017/745), which came into force in May 2021, requires clinical data for the issuing of the CE mark.

In addition, meaningful clinical data are a prerequisite for adequate remuneration when entering the market.

We work with you to develop a clinical strategy tailored to the product, your company and your goals,
determine the key points and the synopsis of clinical studies with you
and are at your side to advise you on the operational planning and implementation of studies