Centaur Clinical determines what are the regulatory product requirements to meet current regulations.
With a 140 m2 laboratory that has the necessary equipment for preclinical testing, Centaur Clinical directly handles the in vitro biocompatibility tests to be considered according to the type of MD, the surface area and duration of contact with tissues and/or blood: cytotoxicity, haemocompatibility, genotoxicity, pyrogenicity.
Sample preparation protocols are drawn up in accordance with ISO 10993_12 . After each carried out test, an evaluation report is drawn up according to the latest standards. The evaluation report will confirm thepreclinical safety and performance of the device thanks to an analysis of all the results of the various tests carried out.
The team’s expertise and knowledge of the ISO 10 993 allow it to supervise, on behalf of the client, a wide range of physico-chemical and in vivo biocompatibility tests done externally.
Centaur Clinical has surrounded itself with qualified partners, offering the best possible service including a protocol/study plan, test performance and evaluation report.
The compilation of the technical dossier requires both scientific expertise and specific experience in the regulatory aspect of the key elements that will be taken into account during the review by the notified body; Centaur Clinical ensures the implementation of essential and relevant tests;
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