FEATURED EDITORIAL
Making The Call On Pre-Validated Packaging
The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? It depends.
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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.
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We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.
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.
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.
Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.
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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