The new ISO 10993-18 and updates to regulatory expectations regarding chemistry in support of medical device biocompatibility
We are happy to announce Nelson Labs will be exhibiting in booth #821 with our sister company Sterigenics at the 2019 BIOMEDevice San Jose tradeshow, in San Jose, California, December 5-6, 2019.
Nelson Labs will have consultants available to BIOMEDevice San Jose participants to answer even the most difficult testing and compliance questions. Stop by booth #821 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’ BIOMEDevice San Jose Events:
Tech Theater Lecture (Free)
Topic: The new ISO 10993-18 and updates to regulatory expectations regarding chemistry in support of medical device biocompatibility
Date: December 4, 2019
Presenter: Dr. Matt Jorgensen
The basic theory of how medical devices should be evaluated for biocompatibility has been in a period of flux. A cornerstone of the new ISO 10993-1:2018 is that evaluation should be focused on a rational and risk-based approach that minimizes unnecessary animal tests. A large part of that approach relies on the use of chemistry and material information to make determinations regarding biocompatibility. Changes to standards (ISO 10993-18) and regulatory policy have complicated this process. This presentation will highlight some key points in the new draft of ISO 10933-18 and provide recent examples implementing these changes in biocompatibility submissions to the FDA.
Dr. Jorgensen is the Senior Extractables and Leachables Chemistry Expert at Nelson Labs. He has over a decade of experience in chemistry and materials science designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes academic research in organic chemistry, computational treatments of various analytical techniques, and as professional in a commercial lab. Most of his materials research has focused on the intersection between chemistry, materials, and physics – fabricating structures with special micro- and nano-patterning to introduce novel functionality. His research has resulted in over 30 peer-reviewed publications, along with many more whitepaper and blog articles.