PDA Midwest: Current Regulatory Environment for Biocompatibility

The PDA Midwest Chapter is pleased to invite you to our Current Regulatory Environment for Biocompatibility Webinar.

Join us on February 24th for an hour long webinar that will provide an overview of ISO 10993-1:2018, the FDA approach to ISO 10993-1 and practical strategies when submitting biocompatibility data. The framework of the multiple parts of ISO 10993 with current testing requirements as they apply to various product types will be discussed, and examples of practical applications will be reviewed.

Speaker: Karen Sargis, Sr. Specialist, Biocompatibility and Toxicology at Hollister Incorporated

Karen has over 20 years of experience in the medical device industry, working as a biocompatibility SME for companies like Cardinal Health, CareFusion, BD and ICU Medical; and, has served as corporate AAMI representative to ISO 10993 working groups for Cardinal Health, CareFusion and BD. She is experienced in providing biocompatibility, sterilization and verification and validation data packages to U.S. Food and Drug Administration (FDA) and to agencies outside of the U.S. for review in support of new and modified medical devices (reusable surgical devices, implantables, consumable respiratory devices, intravascular devices and combination drug/device products), documenting EU MDR packages for various types of products and documenting biocompatibility remediation test plans for legacy on-market products. She is currently part of the Biocompatibility/Toxicology team at Hollister Incorporated where she is supporting ostomy, continence, wound, and critical care products.