Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO 10993-18 as part of TC 194 / Working Group 14.
Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again! Our Director of Analytical Chemistry, and International Delegate for ISO 10993 part 18, Sandi Schaible explains why chemical characterization should be the driver behind your biocompatibility testing plan.
With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.
Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the endpoints you need to support your products’ safety.
Visit the WuXi AppTec exhibitor booth #513 at DeviceTalks Boston, which takes place Oct. 8-10, 2018. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that will meet the endpoints you need to support your product’s safety.
WuXi AppTec Associate Director of Regulatory Toxicology Vanessa Haase, PhD, will present on biocompatibility testing as part of biological evaluation and ISO 10993.
Join WuXi AppTec’s technical and regulatory experts as we share our experience with ISO 10993 and what that guidance means for today’s medical device manufacturers.
On the first day, our team will share case studies regarding how Global Regulatory bodies currently interpret the guidance. As part of the working groups, our team will also share the upcoming changes to ISO 10993 parts 1, 17 and 18 and what those changes may mean moving forward for medical device manufacturers.
The second day is a deep this deep-dive into ISO 10993 Part 18. Sandi Schaible will look at the upcoming changes to ISO 10993 part 18 and what they may mean to chemical characterization test plans in the future.