Q1. What is Clinical evaluation?
Q1. What is Clinical evaluation? Ans. Clinical evaluation is a methodologically sound procedure to collect, appraise and analyse clinical data related to a medical device and to assess whether there is sufficient clinical evidence to confirm compliance with the general safety and performance requirements of the device when it is used as intended by the manufacturer. it is done, initially to obtain CE marking of the device and for placing the device in the market but updated thereafter periodically as new information becomes available from ongoing research works or literatures published. The clinical evaluation is based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the device. There are 4 different stages in performing clinical evaluation: Stage 0: Scoping and planning of clinical evaluation Stage 1:Identification of pertinent data (identifying relevant pre-market and post-market cli...