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In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.Sponsor:This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at cleio.com.Key Timestamps:[02:15] - Sara recounts her experiences with FDA inspections.[05:30] - Etienne introduces the sponsor and the episode’s focus on QMS.[12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.[19:45] - Discussion on the practical steps to build and customize a QMS.[34:10] - Sara’s sourdough analogy to illustr