The customer is an American multinational leader in Medical Devices. One of its newly developed wearable devices for Cardio-Pulmonary vital measurement failed a biocompatibility test which caused a delay in medical device regulatory submissions and the product launch. HCLTech’s medical domain experts investigated the test failure by performing root cause analysis through a globally accredited test facility using a unique design of experiments. Internationally certified HCLTech biocompatibility and toxicology consultants led the investigation and reporting.
HCLTech provides world-class biocompatibility testing support across all classes of medical devices. HCLTech’s team of well-qualified and certified toxicologists helps customers ensure that their products are safe and compatible.
HCLTech has supported and collaborated with more than eight leading medical device OEMs. HCLTech has extended its engagements with medical device manufacturers by completing 25+ projects covering an exhaustive list of implants, disposables, hospital supplies, and life-sustaining devices. Projects involve biocompatibility compliance checks with the respective regulators, conducting in vitro and in vivo pre-clinical testing, generating high-quality reports, and assisting manufacturers in achieving full compliance in terms of biological safety. HCLTech is associated with globally recognized OECD Good Laboratory Practice (GLP) and ISO 17025:2017 accredited Laboratories for addressing all the pre-clinical testing requirements listed in the 10993 series. HCLTech provides overall support from test recommendations to biological safety evaluation report preparation, helping medical device manufacturers to achieve hassle-free market approval across all regulatory bodies.