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.
Don Pohl (Manager of Biological Safety and Validation, NAMSA)
Date: Tuesday, February 5
Time: 8:30am - 9:10am
Track: Classroom Seminar
Vault Recording: TBD
Audience Level: All
Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.
In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. And, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety. This informational session, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements.