FEATURED EDITORIAL
Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?
The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.
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Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
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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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Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
INDUSTRY INSIGHTS
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The Mold Is Only Half The Story
In micro molding, automation isn’t an add-on. Learn how integrated handling, inspection, and packaging enable scalable, high-quality production.
In micro medical manufacturing, prototype success doesn’t guarantee production success. Learn how tolerance strategy, tooling, and metrology ensure reliable assembly at scale.
In emergencies, scarce data delays decisions. Remote sensing — radar, thermal, and vision — assesses patients at a distance, enabling faster triage, smarter resource use, and more informed care.
Autonomous IV therapy extends care beyond clinics, using imaging, precision control, and adaptive intelligence to improve vein access and enable safe treatment in more settings.
Micro 3D printing helps OEMs validate designs, reduce risk, and accelerate development before tooling, enabling more confident decisions and smoother transitions to production.
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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