regulatory safety testing Tag

How to Address Unexpected Genotoxicty Signals in Safety Testing of Medical Devices

[vc_row][vc_column width="2/3"][vc_column_text]As outlined in the updated ISO 10993 standards, genotoxicity assessment is becoming increasingly important in the biological evaluation of medical devices. Now, genotoxicity assessment is not only required for long-term contact devices, but also for less invasive devices with prolonged contact. Traditional genotoxicity testing strategies...