ISO 10993 Biocompatibility & Toxicology Testing Services for Medical Device

IngenesTM provides ISO 10993 Biocompatibility and Toxicology testing services for medical devices in partnership withGLP Certified and ISO 10725 standard accreditedlaboratory with state-of-the-artfacility and best-in-class infrastructure equipped with animal rooms that are built as per international standards. Our FDA Consultant, who is a subject matter expert that specialises inmedical devices will recommend the studies required for the device.

Our medical device testing services are provided as per the requirements of ISO and FDA medical device regulations. Our ISO 10725 standard compliant GLP Certified laboratory has the capability to perform preclinical evaluation of medical devices and biocompatibility testing for surgical, urology, plastic surgery, orthopaedic, dental, ophthalmic, cardiovascular, respiratory, PPEs andwound care products.

IngenesTM routinely performs biocompatibility & toxicology studies on medical devices in OECD GLP certified and ISO 17025 accredited Laboratoryas per ISO 10993. The data generated at IngenesTM has been well accepted by USFDA for 510(k) & PMA submissions, EU (for CE Marking) and other regulatory agencies. IngenesTM clientele includes National and International medical device companies from US,UK, Canada, India, and China.