FEATURED EDITORIAL
Improving Execution Of Biological Evaluation Of Drug Delivery Devices
This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.
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While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.
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FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
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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.
INDUSTRY INSIGHTS
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Optimizing Packaging Layers: Test Protocols For Device Protection
Understanding how packaging levels interact and support overall package integrity is critical for ensuring regulatory compliance, preserving product performance, and delivering safe, effective devices to patients.
Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued market access.
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.
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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