CLINICAL-EVALUATION-AS-A-SERVICE
Verify the safety and performance of your medical device as well as its clinical benefits – all throughout its life cycle.
Ensuring that the benefit outweighs the risk
A medical device needs to be effective and to provide more benefits than risks when used as intended by the manufacturer. These requirements are verified by means of the clinical evaluation, which is a systematic and planned process to continuously generate, collect, analyze, and assess clinical data relating to the device in order to verify the safety and performance of your product and its clinical benefits.
Clinical Evaluation: An ongoing process throughout the entire life cycle
Clinical evaluation is not over after you’ve received the CE mark. It has rather to be performed throughout the entire life cycle of medical devices – starting in the early stages of development and reaching far into post-market surveillance activities for the purpose of post-market clinical follow-up.
Finding the appropriate level of clinical evidence is difficult and is one of the most discussed issues among manufacturers in complying with the MDR requirements.
This is why THE FORCE advises you on the right path, best source, and a reasonable level of data to be compiled. We enrich this approach with our profound experience and knowledge as well as with professional opinions from our network of medical practitioners and established key opinion leaders.
