FEATURED EDITORIAL
Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts.
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P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
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The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.
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An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
INDUSTRY INSIGHTS
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Navigating Recent Changes To USP <788>
A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.
ISO 10993-7:2026 replaces table-based EO residual limits with a risk-based framework that requires manufacturers to justify limits based on device-specific and patient-specific factors.
Discover why micro molding requires a complete manufacturing architecture integrating design, tooling, automation, metrology, production, and packaging to achieve predictable, repeatable results at scale.
Drug developers and device engineers share more common ground than their distinct disciplines suggest, facing parallel pressures around design, safety, regulatory approval, and scalable performance.
Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and accelerates development schedules.
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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