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BIOMEDevice San Jose

December 8, 2021
December 9, 2021

San Jose, CA

Mike Pizzi
+1 (801) 290-7524

We are happy to announce that Nelson Labs and Sterigenics will be exhibiting at the BIOMEDevice expo in San Jose, California, on December 8th and 9th, 2021. Visit us in booth # 821.

Nelson Labs and Sterigenics will have consultants available to answer even the most difficult testing, compliance, and sterilization questions. Stop by the booth for a complimentary, personalized 30-minute consultation. Also, mark your calendar for our educational lectures (details below).

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.

We hope to see you there!