Clinical studies with medical devices are regulated by EU regulations, the Medical Device Act, Ordinance on clinical trials with medical devices and the ISO 14155. However, certain flexibility is given, especially with regard to the choice of the study design, the selection of study objectives and the study duration.
Due to the MDR, clinical studies are mandatory if the clinical evidence of safety and the aspired clinical benefit in the intended use are not sufficiently proven by clinical data of the respective product. A clinical study is mandatory for implantable and class III products, with only a few exceptions.
We offer you an individually adapted strategy, which covers your overall objective in various ways, e.g. in terms of the CE certification, the approval in non-European countries or the extension of the current intended use.
We can support you in a wide variety of studies, ranging from single-arm studies, post-market clinical follow-up studies (PMCF studies) to complex randomized controlled studies.
- Highly competent preparation of a concept under the supervision of experienced clinicians and statisticians
- Prompt transfer of the study concept into the necessary study documents
- Time efficient submission of clinical studies to the required authorities and Ethic Committees through nearly 20 years experience in this field
- Consideration of the newest developments in the field of benefit assessment of medical devices
Following seminars are available in this context:
- German Medical Device Act seminar for investigators (Flyer)
- Clinical studies with medical devices for sponsor personnel (Flyer)
- Monitoring of medical device studies for CRAs (Flyer)