Support tailored to your needs
As a reliable partner in the field of clinical research with medical devices, we plan and conduct research projects e.g. clinical investigations and Post-Market Clinical Follow-up (PMCF) investigations in accordance with the current relevant national laws and international standards (ISO 14155:2020) in various application areas with a high standard of quality.
Our team of qualified specialists draws on years of experience in the medical device sector/ industry and supports our clients with in-depth expertise. The main focus of our work so far has been on Germany and Europe.
We will gladly advise you on study planning, taking into consideration national and international regulations e.g. EU regulation 2017/745 (Medical Device Regulation, MDR), MPDG (Medical Device Law Implementation Act) and MPAMIV (Medical Devices User Notification and Information Ordinance).
for medical devices