FEATURED EDITORIAL
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
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This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
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Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
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Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.
INDUSTRY INSIGHTS
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Accuracy, Safety And Ease Of Use
Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.
Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
Packaging shapes how devices are understood, handled, and used. A human-centered approach surfaces critical info sooner, reduces errors, and strengthens safety and usability.
Build regulatory strategy into your company from day one — not as support, but as a core driver of value, risk management, and successful commercialization.
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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