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Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines

Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993. On June 16, 2016, the U.S. Food & Drug Administration (FDA) expanded and clarified how manufacturers should comply with the ISO 10993-1 … Continued