Clinical trials are becoming more and more important in order to evaluate the safety and performance of medical devices. The clinical evaluation is one of the most critical parts of Technical Files in order to obtain product approval.
Merc will analyze your products to determine the possible need for a clinical study, and will help you find the best regulatory strategy to obtain approval in any country of the world.
Our solutions are based on the existing clinical trial regulations (ISO14155 and Good Clinical Practice).
We can follow the whole implementation of a clinical strategy, including the definition of a Clinical Protocol, the submission of the relevant applications to the Competent Authorities and Ethics Committees, the Management and Surveillance phases, the Final Report and the Clinical Evaluation.
Clinical evaluation of product must be carried out according to specific performance and safety standards, which have been introduced by the Medical Device Directive and new Regulation 2017/745.
Merc will assist you with the Clinical Evaluation of your products according to actual requirements.
Merc provides assistance with all activities related to the management of Clinical Studies.
Merc will support Studies activities for their entire durationby developing appropriate documentation and answering all questions that may be posed by the authorities.