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Episode 1 - IEC 62304 with Cathy Wilburn
Cathy Wilburn, the Director of Quality Assurance and Compliance at The RND Group | A Gener8 Company, sits down with Anna to discuss IEC 62304, an international standard for medical device software development which is followed by both the FDA and EU. Cathy fact checks some common myths and even provides a companion guide for the 'Top Five FDA Readiness Assessment Findings' that the RND Group has come across.