During the formulation and manufacturing of polymeric materials for medical devices, the materials go through multiple stages and undergo many transformations. At each of these stages new additives might be added or the material is exposed to physical factors like heat which impacts the chemical nature of the ingredients. Subsequently, during the final product lifecycle these compounds might migrate into the patient body causing unintended harmful consequences. ISO 10993 regulations include the requirements for chemical testing of medical devices to demonstrate the possible migration and identification of the migrating species. High resolution mass spectrometry and scientific data systems can help analysts meet the regulatory requirements and ensure patient safety.
About the Speaker
Dr. Cabovska holds a research degree in analytical chemistry and has over 10 years of experience in extractables and migration application. Dr. Cabovska is currently a senior business development manager at Waters Corporation, located in Milford, MA – USA where she actively collaborates with customers on providing comprehensive materials characterization solutions across extractables and migration testing applications. Before joining Waters, Dr. Cabovska focused her work on Bioanalytical method development and validations for therapeutic drug monitoring and extractable and leachable studies in packaging.
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