The Power of Extractable/Leachable Chemistry Testing for Medical Devices

This webinar summarizes how extractable/leachable chemistry testing for medical devices can save time and money for manufacturers preparing for a 510(k) submission. A few of the strategies and options are explained for conducting an extractable/leachable chemistry study according to ISO 10993 standards, leading up to case studies that illustrate the power of chemistry testing as an integral part of the biocompatibility evaluation plan. Chemistry has become integral to understanding the safety of medical devices, and the regulatory environment is trending towards an even greater reliance on the chemistry of device materials. Any person in the medical device industry with a hand in the design, engineering, or submission of devices for regulatory approval will benefit from a broader understanding of how extractable/leachable chemical analysis will play a role in the assessment and approval of their devices. Complex chemical structures and mathematical formulae are omitted from this presentation, so the only prerequisite is a desire to learn.