Welcome to episode one of YSK Gener8 podcast. Gener8's capabilities are vast and varied, and we want you to know exactly what you should know about the hottest industry topics. Learn more with us each episode as we take a deep dive into topics specific to Life Science markets and more.
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.