Full support and care
Preclinical tests
In Vitro
In Vivo
Characterisation
physico-chimique
Biological risk assessment in accordance with ISO 10 993
Assessing the biological safety of your device
Centaur Clinical CRO helps you demonstrate the biological safety of your device by identifying your needs with the help of its expert biologists and toxicologists, and by carrying out biocompatibility tests in accordance with ISO 10 993 and good laboratory practice.
Physicochemical characterization
following ISO 10 993-18
TRA: Toxicological Assessment
following ISO 10 993-17
BEP: Biological evaluation plan
ISO 10 993-1 and MDR 2017/745
Testing
following ISO 10 993-1 (in vivo, in vitro)
BER: Biological Evaluation Report
ISO 10 993-1 and MDR 2017/745
To find out everything you need to know about preclinical testing, download our white paper in .pdf format.
Call on our team of experts for dedicated, optimised support
Because time is your ally, take advantage of our expertise and experience to bring your medical device to market.
TESTIMONIALS
Our satisfied customers are talking about us
We are starting a clinical investigation with Centaur Clinical and are very satisfied with our collaboration so far. Preparing the submission to the authorities is a stressful and time-consuming period that requires skilled staff. The Centaur Clinical teams are always ready to provide us with their expertise, availability and support.
Centaur Clinical helped us to define a rationale and a solid, coherent clinical investigation strategy in line with the expectations of Notified Bodies regarding the application of the MDR and the necessary clinical evidence to provide.
