MDR Consultancy
For those seeking clarity on clinical data required by MDR.
It is not possible to self-proclaim oneself an expert in MDR, because for everyone, including notified bodies, this is a new world to explore. However, there are precise guidelines (MDCG 2020-7, 2020-8) and standards (ISO 14155, ISO/TR 20416) to follow, and experience accumulated in daily practice and in discussions with auditors helps to unravel doubts.
With a simple chat we can understand what you need and how you can leverage your assets to address the requirements of the new Medical Device Regulation.
