The Clinical Evaluation Demonstration of clinical safety and performance

Clinical Evaluation is key for the demonstration of the clinical safety and performance of the devices. Why is it so important?

Because manufacturers have to demonstrate the compliance of their devices with the Essential Requirements. They have to show that the products they put on the market do not present any unacceptable risks compared to their clinical benefit and that the devices will provide the expected performance based on their intended use and during normal conditions of utilization.

This is relevant not only before placing a new device on the market, but it is also expected that the manufacturer will monitor its clinical performance and safety as part of the Quality Management System once the device is commercialized.

– Is the clinical evaluation mandatory for all types of medical devices?
– Why is it so important?
– What is the best methodology to demonstrate and confirm the clinical performance and safety of the device as requested by EU MDD?
– What does the Notified Body look at to assess the clinical evaluation?
– How the process can be part of the Quality management system?
– What are the common mistakes to avoid?
– Will the new MD regulation introduce any new requirements in regards to the clinical evaluation?

For the answers to these questions, and more, you can tune to LNE/G-MED North America’s upcoming Free webinar on The Clinical Evaluation — Demonstration of clinical safety and performance