The EU Regulation on medical devices and the continuously growing requirements for quality of clinical data and technical documentations pose great challenges for the manufacturers of medical devices. The devices are categorised into the Classes I, IIa, IIb and III in consideration of their intended purpose and therefore their risks. This classification determines the applicable conformity assessment procedure. Quality management systems have to be established accordingly. Manufacturers classify their devices themselves, but notified bodies have to be involved and can object to the classification.

Do you want to conduct a clinical investigation for a CE marking or need assistance in a Post-Market Clinical Follow-up (PMCF)?

Benefit from our long-term experience and reliable methods of working the conduct of various national and international clinical studies (among them several long-term observational studies). We developed efficient and cost effective processes and perfected them over time, so we can ensure, that nothing is left to chance. In us, you have found a reliable partner, that will take your individual needs seriously.