We prepared a final clinical evaluation report with examples about a medical device’s general safety and performance requirements based on the clinical data during the pre-market and post-market ...

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 ...

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 ...

Literature search protocol for medical devices should be developed and executed by identified persons with expertise in information retrieval, having due regard to the scope of the clinical evaluation ...

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 clinical evaluation plan is a detailed document that outlines the systematic approach and strategy for evaluating the clinical performance and safety of a medical device. It serves as a roadmap for ...

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 ...