pfmmedical expert specialises in providing advice on all regulatory requirements for medical devices in accordance with the MDR (EU Medical Devices Regulation) as well as support in clinical project management and quality management. Our team consists of academics and highly qualified specialists with different specialisations. Together, we have over 150 years of accumulative experience, which we use to develop the right clinical and regulatory strategy together with you.
Our portfolio includes, for example, statistical evaluations and analyses, clinical studies and assessments, database systems, programming, and provision of electronic patient record forms (eCRF) and support with the CE certification of your medical devices.
Our offer is aimed at established medical device manufacturers and ambitious companies that want to enter the European market. We offer solutions that are tailored to your company and your products.