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In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through before they receive regulatory approval.

This biocompatibility risk-based approach evaluates the risk of the device through consideration of the device’s cytotoxicity, irritation, and sensitization. 

• Cytotoxicity – Will the device kill or harm the cells it comes in contact with?
• Irritation – Will the device make contact with the patient and cause skin irritation? (Redness and/or Swelling)
• Sensitization – Will the device cause an allergic reaction?

Listen to the full episode “Intro to Pre-Clinical Testing and Biocompatibility” now!

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