Centaur Clinical takes care of the identification of product requirements as well as preclinical testing according to current regulations.
Equipped with a 140 m² laboratory, Centaur Clinical handles the in vitro biocompatibility tests to be considered according to the type of DM/DMdiv, the surface area and the duration of contact with tissues and/or blood (bold tests are performed in our laboratory):
– ISO 10993-3: Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests
– ISO 10993-4: Selection of tests for interactions with blood
– ISO 10993-5: In vitro cytotoxicity tests
– ISO 10993-6: Tests for local effects after implantation
– ISO 10993-10: Tests for irritation and delayed hypersensitivity
– ISO 10993-11: Systemic toxicity tests
– ISO 10993- 12: Preparation of samples and reference materials
– ISO 10993-18: Chemical characterization of materials
– ISO 10993-23: Irritation test
In order to provide our customers with a turnkey CE marking, we have established partnerships with selected subcontractors with our quality criteria for the performance of the remaining tests (see above).
In order to ensure quality, our laboratory is committed to GLP compliance.
After each test, an evaluation report is written according to current standards. The evaluation report must provide evidence of the safety and performance of the device through an analysis of all the results and interpretations of the various tests performed.
The preparation of the technical file requires both scientific and regulatory expertise of the key elements that will be taken into account by the Notified Body.
Centaur Clinical brings you this double competence to ensure the implementation of essential and relevant trials.