PDA Midwest is delighted to present industry experts from ICU Medical and WuXi AppTec. Karen Sargis, Biocompatibility Manager at ICU Medical, will be presenting on biocompatibility requirements for product evaluation. Dr. Vanessa Hasse, Associate Director of Regulatory Toxicology at WuXi Apptec, will be presenting on Biocompatibility Testing as part of Biological Evaluation and ISO 10993.
Biocompatibility Requirements for Product Evaluation
Biocompatibility testing is a growing area of interest in the development and registration of combination products. This session will focus on the basic concepts of biocompatibility testing for device platforms, as well as the strategies to execute them in a meaningful way such that excessive animal testing is not required.
Biocompatibility Testing Methodologies
Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Some common tests are cytotoxicity, sensitization and irritation tests; however, other test methods may be needed based on usage of the product. ANSI/AAMI/ISO 10993-1 describes the process for biological evaluation of medical devices and the tests that are required. This presentation will provide detail into the test methods.
This dinner meeting will consist of a networking hour, dinner and presentations from our guests.
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|Event End Date||09-20-2018|
|Location||Crowne Plaza, Northbrook IL|