In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains to Clinical Evaluation. At QualityMedDev website, we have previously explored

There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro Diagnostic Regulation; this is why having a well documented clinical

The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on a medical device, in order to evaluate its safety and

Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance. The evaluation is based on a comprehensive analysis of