Exloration of High Risk Medical Devices Methodologies for Optimized Evaluations

Medical devices are developed by manufacturers that need to provide proofs of safety, efficacy, efficiency. In the same time they could be specialists in the technologies, they could not be necessary experts for the targeted medical field and need to be surrounded to build the correct clinical evaluation strategy. Skills required are specific to these particular instruments, and need to be optimized and innovative, as there is as much different devices than the start-ups in the arena. Even if works are performed on the methodological aspects since years, we propose to state a snap of the situation thanks to clinical trials databases exploration, with the aim to extract typical cases for future help and support for the actors. The current article offer to present our strategy of work as well as first quantitative results.