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    Tradeshows

    BioMEDevice

    Register Now!

    We are pleased to be returning to San Jose to attend 2021 BIOMEDevice LIVE!

    We will be exhibiting in Booth #821 with our sister business Nelson Labs. Stop by and meet our experts who are available to answer your questions on testing and sterilization to help ensure the safety of your product and process.

    And…don’t miss these Nelson Labs events

    Tech Theater Lecture
    Topic: Current Regulatory Trends Around Extractable and Leachable (E&L) Testing: What We Are Hearing from the FDA
    Date: December 8, 2021
    Time: 1:30 PM – 2:15 PM
    Location: Tech Theater
    Presenter: Thor Rollins, Director of Toxicology and E&L Consulting

    Are you still confused about when to perform E&L testing for an FDA submission? How do you know that the testing you have done, or are planning to perform, will meet the FDA’s strict requirements? In this talk, Thor Rollins will cover the concepts of E&L testing and discuss when it is required to run these tests for regulatory approval. He will also cover the most recent FDA feedback and direction around the testing and what you can do to make sure the testing is prepared for your submission.

    Center Stage Lecture
    Topic: The Evolution of the Biocompatibility Evaluation Plan
    Date: December 8, 2021
    Time: 11:15 AM – 12:00 PM
    Location: Center Stage
    Presenter: Thor Rollins, Director of Toxicology and E&L Consulting

    Biocompatibility evaluation plans (BEP) are rapidly becoming an integral part of your device submission. These BEPs have evolved over the past few years and now must include more than they ever have included before. This presentation will cover the current expectations from the FDA and notified bodies on BEPs, what must be included, and what format works best with submissions. Learn from industry expert Thor Rollins as he discusses the following topics:

    • Incorporating shelf-life evaluations into your biocompatibility plan.
    • How to include extractable and leachable studies and what testing can be evaluated with its results.
    • Ways to justify out of certain tests.
    • Submitting and presenting your BEP.

    QUESTIONS

    Contact Amie Casson aecasson@sterigenics.com