If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must ...

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 ...

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 ...

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 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 ...

EU 2017/745, the requirements for medical device clinical trials are part of Art. 62 through 82 and Annex XV. EU 2017/745 enforces all manufacturers must clinically evaluate a medical device before ...

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 ...

A performance evaluation plan report is an important step for in vitro diagnostic devices that serves to meet IVDR EU 2017/746 general safety and performance requirements. Part A of Annex XIII ...

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 ...

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