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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Your Quality Team Is Already Using AI To Draft Compliance Documents
Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.
Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.
Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.
Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.
A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.
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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