We are happy to announce Nelson Labs will be exhibiting in booth #3029 at the 2019 MD&M West tradeshow, in Anaheim California, February 5-7, 2019.
Nelson Labs will have consultants available to MD&M participants to answer even the most difficult testing and compliance questions. Stop by booth #3029 for a complimentary personalized 30 minute consultation, and mark your calendar for Nelson Labs’ educational lectures, and roundtable debate (additional details provided below).
Nelson Laboratories’ MD&M West Events:
Tech Theater Lecture (Free)
Topic: Becoming Compliant with the MDRs, A Real Life Case Study
Date: February 5, 2019
Time: 1:30 PM
Presenter: Matt Jorgensen, PhD, Chemistry and Materials Scientist
Full Day Seminar Track (Free) Register Now
Topics: Medical Device Validation- Biocompatibility Testing, Cleaning, Sterilization and Packaging
Date: February 6, 2019
Time: 8:30 AM to 4:45 PM
Presenters: Thor Rollins, Wendy Mach, Alpa Patel, Martell Winters, Matt Jorgensen, Nicole Palluck
See below for the view the full agenda.
Biocompatibility: Applying the New ISO 10993 Standards
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC
- 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?
Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
Speaker: Matt Jorgensen, PhD, Chemistry & Materials Scientist, Nelson Labs, LLC
- 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
10:30-10:45 am- Break
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.
12:00 – 12:45 pm ISO 10993 Workshops
Hands-On Biocompatibility Training- Thor Rollins and Matt Jorgensen, PhD
- How to categorize devices
- Hands on sample preparation discussion ( know when to use coupons and how to represent a final device)
- Hands on E&L examples
12:45 – 1:30 pm Lunch Break (lunch not provided)
Radiation Sterilization: A discussion on new options, testing packaging, and failures
Speaker: Martell Winters, Director – Scientific Competency, Nelson Labs, LLC
- 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
2:30- 3:30 pm
Package Validations – a look at current and future state testing
Speaker: Wendy Mach, Consulting Manager, Nelson Laboratories, LLC
- MDR changes to the packaging process
- Overview of Common Packaging test methods
- Sample size considerations
3:30- 3:45 pm Break
3:45- 4:45 pm
Upcoming challenges for cleaning validation studies for reusable medical devices
Speaker: Alpa Patel, Senior Scientist, Nelson Labs, LLC
- 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?
About MD&M West: Delve into the latest challenges and opportunities that are impacting medical device design & manufacturing with the 2019 MD&M West Conference. Hear from the industry’s brightest and gain valuable insights that will help you overcome the most crucial challenges from concept to market. Build your knowledge and your network at this annual industry gathering.