through the MEDICAL DEVICE REGULATION (MDR)
Technical documentation, quality management and co.
on the subject of approval of medical devices in the EU
We accompany you on the way to the utilization of your medical device.
We help you through the CE certification of your medical device.
In Europe, before medical devices can be approved and placed on the market, manufacturers must guarantee the safety and performance of their product throughout its lifetime.
The evaluation as well as the demonstration of safety, performance and benefit is carried out based on clinical data in a clinical evaluation and must be continuously assessed through ongoing market surveillance The clinical evaluation is an essential part of the conformity assessment procedure for CE marking for all medical device classes, and is required for every medical device.
The European Medical Device Regulation (MDR) 2017/745 significantly increases the requirements on the scope and quality of the required clinical data. In this context, the collection of own clinical data moves into the focus of the MDR and represents a major challenge for all medical device manufacturers. Without sufficient clinical data, approval of medical devices in Europe is no longer possible. Medical device manufacturers are then obliged to collect their own clinical data as part of a clinical trial.
Quality management for medical devices
Through the rough waters of the trials,
to the safe harbor of approval.