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.
Due to our active participation on global standards committees, including involvement with technical writing committees for ISO 10993, we understand the intent behind the regulation. We also track regulatory inquiry and responses to predict how regulators interpret new trends and regulatory changes.
Our team of consulting experts includes:
- Leaders and active participants on international standards committees, including multiple ISO 10993 committees, ASTM, AAMI and USP
- 21+ Ph.D. and post-doctorate level experts, including a former FDA reviewer
- 32+ Masters-level scientists
Sandi Schaible,Director, Analytical Chemistry
Mark A. Cabonce, M.S., DABT, Director of Technical & Regulatory
Vanessa Haase, Ph.D., Associate Director of Regulatory Toxicology
Cindy Dingee, D.V.M., Staff Pathologist, Assistant Facility Veterinarian, and Manager of Histopathology Department
ISO 10993 Case Studies
Wednesday, August 22, 2018
9:00 am – 4:00 pm
ISO 10993 Part 18 Deep Dive
Thursday, August 23, 2018
7:30 am – 12:00 pm
Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814
Don’t Miss this Unique Opportunity
Space is limited