What is Cytotoxicity, Irritation, and Sensitization?

 

In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelsons Labs explain the risk-based biocompatibility evaluation that all medical devices have to go through before they can be put to market.

 

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!


About Nelson Labs

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Labs for our:

  • Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
  • Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
  • Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
  • Metric-driven testing processes. We’re our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.
  • Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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