Biocompatibility and Nitinol Guidances

Medtech Matters - En podkast av Medical Product Outsourcing - Tirsdager

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including:What is the biocompatibility guidance in regard to?Does this help simplify the pathway to market for commonly used materials that have a proven ...

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