Loading...

Home

Centaur Clinical is a Contract Research Organization
specialized in the pre-clinical testing and clinical trials for medical devices

PRECLINICAL

With its 140m2 laboratory, Centaur Clinical is capable of conducting preclinical testing in accordance with ISO-10993 and Good Lab Practice.
Contact Preclinical Team

CLINICAL

Centaur Clinical’s expertise is in the field of Clinical Operations, and thus we can take care of your clinical trial projects, from the early stage design to the post market phase, in accordance with ISO 14155 and Good Clinical Practice.
Contact Clinical Team

REGULATORY WRITING

Using the current regulatory processes, EU MDR (Medical Device Regulation (EU 2017/745)), Centaur Clinical writes up and prepare the documents necessary for the submission to the regulatory or notified body.
Contact Regulatory Team

A multilingual team will provide you a dedicated and optimal support.

Centaur Clinical helps manufacturers with the CE marking of the medical devices, including diagnostics, from the pre-clinical to the clinical trial stage and to the post-market phase.

Thanks to the team’s experience in various type of devices and therapeutical areas Centaur Clinical can provide an unrivalled expertise. Centaur Clinical also has a network of partners to help you with areas such as Data Management, Biostatistics, Clinical Operation in other continents, according to your needs.

Quality

Centaur Clinical has implemented a quality management system following the requirements of the Medical Device World Reference Standard: ISO 13 485: 2016. The application of these requirements allows us to control the constraints of our clients from design to regulatory drafting.

Centaur Clinical was certified by AB certification in July 2021.

Centaur Clinical guarantees its services in accordance with good practices (GPC, ISO 14 155) and the regulations in place.

DO YOU HAVE A QUESTION, A PROJECT? CONTACT-US!