HCL Expedites Biocompatibility Failure Investigation to Meet Regulatory Submission Deadlines

Pretty much excited to share our team's first business case study over a successful failure investigation for a customer. HCL Material CoE supported them in re-designing their protocols, conducting testing and finally proving the device safety.

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. HCL’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 HCL biocompatibility and toxicology consultants led the investigation and reporting.?

HCL provides world-class biocompatibility testing support across all classes of medical devices. HCL’s team of well-qualified and certified toxicologists helps customers ensure that their products are safe and compatible.?

For more info: HCL Expedites Biocompatibility Failure Investigation to Meet Regulatory Submission Deadlines | HCL Technologies

PS: Sincere thanks to the co-authors - Mr. Mathiyazhagan M (DU head) and Dr. Mathiyazhagan R (Pre-clinical scientist) for their technical support in successfully decoding the failure.