Clinical Studies
Clinical studies with medical devices are regulated by the requirements of the MDR, the MPDG, the Declaration of Helsinki, the GDPR and ISO 14155, but there is a certain amount of leeway. This includes, among other things, the choice of the study design, the study objectives and the duration of the study. The revised ISO 14155 published in 2020 specifies some essential requirements, such as the applicability of the standard for different clinical development stages or the closer integration of risk management and clinical studies. We offer you an individually adapted strategy that optimally takes into account your overarching goals, such as CE certification, obtaining reimbursement, approval in non-European countries or the expansion of the current intended purpose.
We support you in all types of studies, from "other studies" and post-market clinical follow-up studies (PMCF studies) to complex approval studies.
Your advantages:
- High level of competence in the creation of the concept through the participation of experienced clinicians and statisticians as well as significant in-house expertise
- Fast process of recruiting experienced study sites through our network
- Time savings when submitting clinical studies to authorities and ethics committees thanks to more than 20 years of experience in this field as well as precise knowledge of the expectations of ethics committees and authorities
- Consideration of the latest developments in the area of risk-benefit assessment of medical devices
In addition, we also offer the following seminars in this context:
- Clinical Research under MDR and ISO 14155:2020 (Flyer)
- 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)
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