CENTAUR CLINICAL HELPS MEDICAL DEVICES AND IN VITRO DIAGNOSTICS MANUFACTURER IN THEIR VARIOUS STEPS OF TESTING AND EVALUATION, WITHIN THE REGULATORY FRAMEWORK OF CE MARKING.
The medical device
The team’s experience, knowledge of regulatory guidelines and commitment to ISO 13485 certification make Centaur Clinical a CRO clearly specialised in medical devices and in vitro diagnostic devices.
Within the framework of the MD/IVD regulation 2017/746, Centaur Clinical organizes studies that will make it possible to draw up the performance evaluation report to be submitted to the notifying body
A global approach
Centaur Clinical intervenes from the test phases of your MD. Its laboratory allows you to directly carry out the biocompatibility tests of your device in compliance with GLP. Our team can then take charge of compiling the files to be submitted to the notifying bodies, work with you to design the clinical trial adapted to your claims and then directly conduct the clinical trial up to submission to the notifying body.
Thanks to its selected collaborations, you can also be supported throughout the entire marketing process: commercial and clinical strategy, market access, data security, etc.
The international dimension
The multilingual profile of the team and the many partnerships already established around the world allow us to provide test coverage in almost every corner of the globe. In addition, the team’s knowledge of FDA and other country regulations enables it to incorporate the relevant criteria for future extensions in the desired countries from the outset.
Centaur Clinical has taken on projects in a wide variety of therapeutic areas. The studies were mainly conducted in the fields of:
- – Oncology
- – Cardiology
- – Resuscitation