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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.


Dr. Phillip Smiraldo, Ph.D., DABT (Medical Research Scientist, NAMSA)

Location: 209B

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.

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