CRO specialising in medical devices
Turnkey support from prototype through to obtaining or renewing your CE mark.
Our offer
Dedicated support throughout the CE marking process for your medical device
Our expertise in preclinical testing, clinical trials, regulatory drafting and data management means we can take the regulatory and mandatory aspects off your hands, so you can focus 100% on the future development of your business.
You've designed your DM, we'll make it compliant with regulatory requirements.
Preclinical tests
Centaur Clinical CRO has 140 m2 of laboratory space to carry out preclinical in vitro biocompatibility tests on your devices in compliance with ISO 10993 and good laboratory practice.
Clinical trials
As a monitoring specialist, Centaur Clinical CRO takes charge of your clinical trials, from study design to post-market monitoring, in compliance with good clinical practice and the ISO 14155 standard.
Regulatory affairs
Centaur Clinical CRO drafts regulatory documents and submits them to notified bodies and regulatory agencies or ethics committees (ANSM, CPP, ON).
WHY PUT YOUR TRUST IN US?
Get your turnkey CE marking
Centaur Clinical CRO supports DM/DMdiV manufacturers through all the stages involved in CE marking.
The team's experience, knowledge of regulatory guidelines and ISO 13485 certification make Centaur Clinical a CRO specialising in medical devices (MD) and in vitro diagnostic devices (IVDD).
Our team of highly qualified experts in IVDs and MDDs handles all types of medical devices, from the simplest (class I) to the most complex (class III).
We have in-depth knowledge of FDA regulations, making Centaur Clinical the CRO of choice for bringing your products to the US market. What's more, the multilingual profile of our team and the many partnerships we've already established around the world mean we can cover trials almost anywhere in the world.
We offer a comprehensive package that includes all the stages involved in obtaining or renewing CE marking, from in vitro biocompatibility tests to the design of a clinical trial tailored to your needs, including expertise in the regulatory process and medical writing. Our comprehensive package means you can centralise the various stages of the CE marking process with a single point of contact.
The team's experience enables it to set up optimised studies, whatever the class of DM or therapeutic orientation.
As part of our drive to provide our customers with turnkey CE marking, we have formed partnerships with subcontractors selected according to our quality criteria to carry out tests not performed in our laboratory.
As part of our commitment to quality, our laboratory provides you with GLP-compliant results.
Centaur Clinical CRO carries out its preclinical tests in accordance with Good Laboratory Practice and its clinical trials in accordance with Good Clinical Practice.
Centaur Clinical CRO has set up a quality management system in line with the requirements of the benchmark standard for the world of medical devices: ISO 13 485: 2016.
Centaur Clinical has been committed to CSR since 2021.
Because time is your ally, take advantage of our expertise and experience to bring your medical device to market quickly and under the best scientific and regulatory conditions.
Clients
They trust us
