Our clinical evaluation report consultant team based in Bangalore, India, and serving many leading medical device manufacturers across the Globe. We have all the system, procedures, and human ...

The clinical appraisal plan derived from the clinical investigation, post-market activities, and literature must be evaluated. Clinical data, when generated through a well-designed and monitored ...

Identification of an equivalent device and demonstration of its technical, biological, and clinical equivalence with the medical device under clinical evaluation. Medical devices that use clinical ...

A scientific validity report is used to evaluate the performance of an IVD device, according to IVDR Regulation 2017/746. You must do this early in the life of your IVD if you are introducing a new ...

Analyze preclinical and clinical data to ensure that all safety, performance, risk-benefit profiles, and unwanted side effects are met. Clinical data analysis is a crucial component of the clinical ...