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