『US MedTech's New Test: Pure Global on the FDA's TPLC Shake-up』のカバーアート

US MedTech's New Test: Pure Global on the FDA's TPLC Shake-up

US MedTech's New Test: Pure Global on the FDA's TPLC Shake-up

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概要

 This week, the US FDA overhauled its inspection strategy, introducing a "Total Product Life Cycle" (TPLC) approach. This episode of MedTech Global Insights breaks down what this seismic shift means for medical device manufacturers. We move beyond the headlines to explain how the FDA is breaking down traditional compliance silos, demanding a single, unified view of a product from conception to obsolescence. We explore the practical challenges this creates for companies with fragmented data systems and a reactive approach to quality. This isn't just another regulation; it's a new philosophy of continuous accountability that will redefine what it means to be "inspection-ready." A mid-sized diagnostics company recently faced a TPLC-focused inspection. They had strong pre-market data and a decent complaint handling system. However, they were cited because their post-market surveillance data on component failures was not actively informing the design specifications for their next-generation device. The FDA saw this as a critical break in the product lifecycle loop, costing them time and money in remediation. 本期干货: What is the Total Product Life Cycle (TPLC) approach and why is the FDA implementing it now? How does TPLC change the focus of an FDA inspection away from siloed checks? What are the biggest data management challenges companies will face under this new model? Why is a "living" risk management file more critical than ever? How can you prove to an inspector that your post-market data informs your R&D process? What kind of quality management system is required to support a TPLC framework? How does this US-based change impact your strategy for global market access? Are legacy products exempt, or do they also need a TPLC-compliant data trail? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database
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