Particulates in Preclinical Testing: Understanding the Impact on Overall Device Biological Safety
In today’s medical device industry, manufacturers are creating new devices at an exceptionally rapid pace—this is due to the ongoing drive to treat patients in the most effective and least burdensome manner possible. While some of the advancements in medical devices revolve around the development of new materials, others simply involve creating innovative ways to use materials that already have a long, safe history of clinical use. Regardless, confirming the biological safety of a new medical device has been, and will continue to be, one of the most important aspects of medical device development.
More often than not, some form of testing is required to demonstrate biological safety. This can range from chemical characterization, in vitro/in vivo test methodologies and/or particulate testing through device extractions. NAMSA invites you to access our latest White Paper to learn more about biological safety testing methodologies, with a specific focus on the benefits and drawbacks of particulate testing throughout the testing process.
- Importance of Particulates in Biological Safety Testing
- Steps for Particulate Characterization
- Particulates’ Impact on Overall Device Biological Safety
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