Regulatory Framework

As outlined on the European Commission website, EU MDR regulatory framework for medical devices

Our Capabilities:

Enerxen Consulting will deliver, related to the strengthening of post-market surveillance (PMS) requirements for manufacturers and the reinforcement of the rules on clinical evidence (CER):

Enerxen is an experienced, proven, one stop medical device system engineering company, successfully supporting businesses to roadmap and execution of EU MDR PMS and CER implementation.