We are happy to announce that Nelson Labs will be exhibiting with Sterigenics and Regulatory Compliance Associates at the MD&M West 2025 tradeshow in Anaheim, California, February 4th – 6th.
We will have consultants available to answer even the most difficult testing and compliance questions. Stop by our booth, #3135, for a complimentary, personalized 30-minute consultation. Furthermore, attend one of our educational lectures. For details about the different lectures, refer to the information provided below.
Day 1 – Tech Theater Presentation
Topic: ISO 10993-1: Key update on the new revision of this critical standard
Speaker: Chad Summers, Sr. Manager, Scientific Business Development, Nelson Labs
📍Tech Theater, Booth 678
Tuesday, February 4
1:30 – 2:15p.m. PT
This presentation will delve into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for medical devices. The most current updates out of the ISO meetings in October, introduces a more dynamic, risk-based framework. These changes carry implications for device manufacturers and regulatory professionals running biocompatibility studies. In the presentation you will learn:
- Key updates include a stronger emphasis on a risk-based approach, moving away from prescriptive testing protocols.
- New emphasis on chemical characterization, where the new ISO 10993-1 improves the ability to predict device safety and mitigate potential toxicological risks.
- The incorporation of endpoint-specific risk assessment such as changes on devices requiring genotoxicity evaluations.
- End of life evaluations
Attendees will gain insights into the practical implications of these changes, including how to adapt biocompatibility testing strategies, documentation practices, and regulatory submissions. This presentation will also discuss the broader impact of these updates on global harmonization of biocompatibility standards and their alignment with other regulatory frameworks, helping professionals ensure compliance while enhancing product safety and innovation.
Day 1 – Join us for Ice Cream with the Experts!
“All problems can be solved with Ice Cream” ~ Unknown. Join the experts from Nelson Labs, Nordion, and Sterigenics, for a sweet afternoon treat in booth 3135. Our team members will be on hand to answer all your Lab testing, Regulatory, and Sterilization questions. Stop by and connect with us Tuesday.
Free 30 minute consultations available!
Connect with experts like:
🔹 Chad Summers – Biocompatibility (Nelson Labs)
🔹 Dania Cortes & Ilva Mane – Sterilization (Sterigenics)
🔹 Richard Wiens – Gamma Technologies (Nordion)
📍Booth 3135
Tuesday, February 4
3:00pm PT
Day 2 – Join Us for Beer Garden Happy Hour at MD&M West!
Join us outside for the beautiful Anaheim sunsets as Sterigenics and Nelson Labs sponsor the day two MD&M West Beer Garden Happy Hour!
Come celebrate a successful day at MD&M West with Us and meet our Experts, network with colleagues, enjoy refreshments, and live music.
Meet Nelson biocompatibility experts, Sterigenics sterilization experts, Nordion Gamma expert Richard Wiens and others including Regulatory Compliance Associates.
📍Arena Plaza
Wednesday, February 5
5:00 -7:00pm PT
