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Dr. Phillip Smiraldo, Ph.D., DABT (Medical Research Scientist, NAMSA)
Date: Tuesday, February 5
Time: 9:10am - 9:50am
Track: Classroom Seminar
Vault Recording: TBD
Audience Level: All
Medical device organizations that manufacture products that involve patient contact are most often required to perform some level of chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.
Join this session with NAMSA biological safety expert, Dr Phillip Smiraldo, to learn about global regulatory requirements for chemical characterization testing and how manufacturers can use chemical characterization to demonstrate biological safety for their devices.