FEATURED EDITORIAL
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
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The FDA's new QMSR quietly created a harmonized quality framework between the U.S. and Latin America. With high recruitment performance and low cost, conducting medtech trials in the region has key benefits.
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Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique.
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Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
INDUSTRY INSIGHTS
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Small Joint Implants: A New Era With Medureon™ Bionate
Advances in biomaterials address challenges of small joint implants, improving durability, flexibility, and biocompatibility to reduce wear, enhance motion, and support long‑term patient outcomes.
Optimizing UHMWPE implants requires balancing materials, processing, and sourcing to improve performance, reduce risk, and lower costs in medical device manufacturing.
New research highlights how stronger supplier collaboration helps life science organizations reduce risk, improve innovation, and adapt to rapidly evolving technical demands.
Fluidic simulations help developers reduce prototyping cycles, lower development costs, and accelerate time to market through predictive computational flow analysis and modeling.
Contactless patient monitoring works best when designed for real‑world needs. Aligning sensors, accuracy, algorithms, and privacy delivers insight where monitoring falls short.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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