Service Category

Medical Devices

Demonstration of medical device compliance to ISO 10993 and overall biocompatibility is an essential requirement for marketing authorization in all major markets.  Gaining approval for a medical device requires the informed collection and evaluation of data by a qualified expert to ensure a successful device regulatory submission.  Gradient has the technical expertise to develop a holistic biological evaluation tailored to your device, or will review your existing plans and reports for gaps and regulatory pitfalls.