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MD&M West Presentations

Nelson Labs hosted a tech theater and full-day seminar at the 2019 MD&M West tradeshow in Anaheim, CA. The video of the tech theater is available as well as the PDFs of the presentations from the seminar. Contact sales@nelsonlabs.com for more information.

Tech Theater Lecture

Topic: Becoming Compliant with the MDR, A Real Life Case Study
Presenter: Matt Jorgensen, PhD, Chemistry and Materials Scientist

Watch the on-demand video HERE.

Full Day Seminar Track

Biocompatibility: Applying the New ISO 10993 Standards
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs

  • An overview of the new ISO 10993-1
  • Performing a Biological Evaluation Plan
  • Overview of the Big Three including new in vitro alternatives
  • What is needed in a Biological Evaluation Report for the FDA?

Download the presentation slides HERE.

Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
Speaker: Matt Jorgensen, PhD, Chemistry & Materials Scientist, Nelson Labs

  • How extractable/leachable chemistry testing will save them time and money
  • How this testing strategy increases patient safety
  • How approaches to evaluation of biocompatibility are evolving to focus even more chemistry

Download the presentation slides HERE.

Ethylene Oxide: Annual Requalification Review
Speaker: Nicole Palluck, Sterigenics

  • Overview of the Requalification Decision Tree under ISO 11135 Annex D
  • Guidance on how to conduct the Annual Review
  • Discuss possible examples based on output of the Annual Review

Download the presentation slides HERE.

Radiation Sterilization: A discussion on new options, testing packaging, and failures
Speaker: Martell Winters, Director – Scientific Competency, Nelson Labs

  • AAMI radiation dose determination: New methods and options soon to arrive
  • Bioburden recovery efficiency: 50% no longer in the standard, so now what?
  • Bioburden and sterility tests: To test the packaging or not, that is the question
  • Sterility test failures: Tough bugs or contamination during testing, which is it?
  • Sterility assurance level (SAL): Concepts and flexibility

Download the presentation slides HERE

Package Validations – a look at current and future state testing
Speaker: Wendy Mach, Consulting Manager, Nelson Labs

  • MDR changes to the packaging process
  • Overview of Common Packaging test methods
  • Sample size considerations

Download the presentation slides HERE

Upcoming challenges for cleaning validation studies for reusable medical devices
Speaker: Alpa Patel, Senior Scientist, Nelson Labs

  • Recent updates regarding standards that govern reprocessing validations for reusable medical devices.
  • What reprocessing validations requirements are needed for capital equipment?
  • Upcoming changes to cleaning validations for reusable medical devices?
  • What is happening in the endoscope industry?

Download the presentation slides HERE.