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 the regulatory guidelines and its ISO 13485 certification make Centaur Clinical a clearly specialized CRO in medical devices (DM) and in vitro diagnostic devices (DMdiv).
Concerned to bring the best expertise to its customers, Centaur Clinical’s team ensures a regulatory monitoring of the DM/DMdiv sector and offers you its services to bring your product into compliance with the new regulations in force (2017/745-746) since May 26, 2021.
Centaur Clinical: your turnkey CE marking!
Centaur Clinical assist at any phase of your project, since the test phases of your DM. We propose a global offer including all the steps necessary to obtain or renew the CE marking:
– Our laboratory allows you to carry out in-vitro biocompatibility tests of your device in compliance with GLP.
– Our pre-clinical team can also help you with the regulatory process and medical writing.
– Our clinical team will work with you to design the appropriate clinical trial for your claims and then conduct the study until submission to the Notified Body, in compliance with the GCP.
Thanks to its multidisciplinary team and its selected collaborations, Centaur Clinical brings a global offer that will allow you to centralize the different stages of the CE marking process by positioning itself as your one and only contact!
An International CRO
We have in-depth knowledge of the applicable regulations at the FDA. That makes Centaur Clinical a reference CRO in the US market.
Moreover, the team’s multilingual profile and the many partnerships already established around the world allow us to provide you coverage of tests all over the world.
Centaur Clinical is a CRO specialized in DM and DMdiv.
Our team of DM experts ensures the management of all types of medical devices, from the simplest (class I) to the most complex (class III).