What is Material Characterization and How to Use it to Supplement Your Safety Evaluations

Leachable and extractable studies have an increasing emphasis with biocompatibility. Manufacturers are using the data to help supplement safety evaluations to the FDA. In the Innovation Brief we will go over what are leachable and extractables, how you set up a plan for your product, what information will be given in the results, and how you use the data to supplement your safety evaluations.

This presentation was given at the Tech Theater at BIOMEDevice San Jose 2013.

Presented by: Thor Rollins

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