Understanding Biocompatibility of Medical Devices

Understanding Biocompatibility of Medical Devices
– biological evaluation and biocompatibility testing according to ISO 10993

Medical device manufacturers must conduct biological safety (biocompatibility) evaluations for their medical devices to meet regulatory obligations and receive approval to market medical devices. The complexity of this process is increasing due to new regulatory requirements. Do you have an updated strategy for the biological evaluation of your medical device products?

Welcome to join us at the next Medicon Valley MedTech Network meeting to learn more about ISO 10993* and the recent changes in the standard, and understand how to make a biological evaluation of your medical device products.

ISO 10993; Biological Evaluation of Medical Devices – is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body.