Performance Evaluation/Clinical Trials

Clinical evaluation is a comprehensive assessment of a medical device’s safety and performance based on clinical data collected by the legal manufacturer or gathered from independent sources. The CER is a crucial component of the technical documentation required for the CE marking of medical devices in the European Union (EU). The purpose of a CER is to demonstrate that the medical device’s clinical data supports its intended use and conforms to the relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use.

Below points needs to discuss with Nitin Sir  

• Documentation for the presentation on trial protocols to a steering committee
• Design and create the data collection forms as well as case report forms.
• Manage the regulatory authority application of research and marketing of new and old drugs.
• will be conducting the trial with doctors, consultants, and investigators.
• Evaluate and visit the report after that to prepare the final report.

• Support and help in every clinical development process. It provides the benefits and risks of new drugs.