Medical Device Testing Services Manufacturers

Medical Device Testing Services include, determination of bioburden before sterilization, method development & validation, determination of bacterial count on the product before sterilization, sterility testing according to USP & EP of products & biological indicators, test for endotoxins, test for ethylene oxide residue according to DIN EN ISO 10993-7, hygiene monitoring for the qualification and control of production zones, implantation test (muscular, peritoneal, ocular, intraosseous), cytotoxicity testing & biocompatibility according to EN ISO. Regulatory agencies such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers.