{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"Life Science Solutions","title":"(Part 2) ISO 14971 and Risks in Medical Devices: What You Need to Know","html":"","width":"100%","height":180,"duration":1688,"description":"In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation, digging into the complexities of medical devices, including AI and other MedTech. Can risk management keep up with the evolving medical tech landscape? What about complex systems? Let's find out.\nToday's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group.  Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.\nDocumenting medical device risk management through the risk traceability summary\nImplementation of risk management principles and activities within a Quality Management System\nMedical devices — Guidance on the application of ISO 14971\nAbout the Factor:\nThe Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.\n \nAbout Kymanox:\nKymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions...","thumbnail_url":"https://img.transistorcdn.com/NJUQJpllzMReojwXSp4vxSqDlm-PIulGozVxmRVQnJE/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS8yOGM2/NjIwZTU1YjljMDM5/ZGRhMWZhODQ2OTAx/NjliZS5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}