November 8, 2019 | Presenter: Audrey P. Turley
In light of recent changes that are impactful to the realm of biocompatibility, including the new Medical Device Regulation (MDR) out of Europe and ISO 10993-1, this is a frequently asked question. Since 2010, 11 of the 10993-series standards have been updated. This presentation will specifically include:
• Highlight of changes in each standard
• How/if testing was impacted
• How to address/review any gaps
RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & Biocompatibility Expert
Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...
