Header Artwork
Header Artwork

Video Gallery

Video Gallery

Biocompatibility Standard Changes: Is Your Testing Up to Date?

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

 

Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Biocompatibility Expert

Audrey Turley has 20 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), and...