FEATURED EDITORIAL
New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
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Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.
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Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
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What is factoring into market growth for electronic drug delivery devices and why? New market research shares key insights.
INDUSTRY INSIGHTS
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Managing PFAS Uncertainty: What Medical Device Teams Can Do Today
Success requires mapping material dependencies, addressing unintentional exposure, and documenting a defensible rationale for functional materials to ensure supply chain resilience and patient safety.
Implementing deterministic integrity testing with surrogate formulations is essential to identify hidden defects, ensuring biological products remain sterile and potent throughout the supply chain.
The revised ISO 10993-3 emphasizes chemical characterization and risk assessment to evaluate developmental and reproductive toxicity. Learn how to assess devices to ensure patient safety.
Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive approach enhances consistency, reduces risk, and ensures packaging integrity.
Strategic fluidic partnerships simplify complex instruments through custom assemblies and intuitive fittings, reducing assembly errors, improving serviceability, and optimizing overall optofluidic system performance.
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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