High-quality medical equipment is a key determinant in the delivery of quality health care services in the healthcare industry. However, it is a big challenge to understand the different legal ...

If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application. If submitted too ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

We appreciate your question. We prioritize queries that are addressed on our website. Please keep in mind that we do not accept unsolicited email attachments.