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 ...

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 ...

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 ...

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 ...

Medical Device Clinical Evaluation Identify, collect, appraise, and analyze clinical data from clinical investigations, literature, and post-market surveillance to demonstrate the medical device’s ...

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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Please email us the device information and intended, we will be happy to assist you with additional infomation. I3CGlobal assists Medical Device and Invitro Diagnostic device manufactures in preparing ...