Article 61 of EU MDR: An Overview
In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains…
Clinical Evaluation Plan according to EU MDR 2017/745
There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro…
Investigator’s Brochure According to EU MDR 2017/745
The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on…
Clinical Evaluation according to EU MDR 2017/745
Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and…