We help you to meet the complex clinical evaluation requirements of the MDR for your medical device - even the Post-Market Clinical Follow-Up requirements are routine for us.
The clinical evaluation is an ongoing process both during development and after the medical device has entered the market. The clinical evaluation aims to demonstrate the safety, performance and clinical benefit of the medical device. To do so, the clinical evaluation systematically collects and evaluates all available information.
The clinical evaluation documents (= clinical evaluation file) are an essential part of the technical documentation of the medical device. Data from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) bring them up to date.
We can help you to prepare the clinical evaluation file so that your medical device receives regulatory approval quickly.
Our Clinical Evaluators:
We give you everything you need to meet the regulatory requirements of the MDR and MEDDEV 2.7/1 rev. 4 for the clinical evaluation and thus, pass your audit and approval with 100% confidence.
With our support, you will