Medical Innovation Exchange

CER

Role of Clinical Evaluation Report Consultants

Role of Clinical Evaluation Report Consultants     In the dynamic landscape of medical device regulations, ensuring the safety and efficacy of healthcare products is of utmost importance. One of the critical aspects of this process is the clinical evaluation of medical devices. A well-written Clinical Evaluation Report (CER) is vital for demonstrating the device’s safety …

Role of Clinical Evaluation Report Consultants Read More »

Ask the Expert: EU MDR as a Trigger for Innovation

Ask the Expert: EU MDR as a Trigger for Innovation     Much of what has been written about the EU MDR emphasizes the increased regulatory burden that it puts on medical device companies. Giotto Compliance looked at the bright side of the new regulations and viewed EU MDR requirements as a catalyst to drive innovation …

Ask the Expert: EU MDR as a Trigger for Innovation Read More »