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By David Elder, ELIQUENT Life Sciences
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Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
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By Julio G. Martinez-Clark, CEO, bioaccess
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Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?
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By Partha Anbil, Life Sciences Industry Advisor, MIT Sloan Career Development Office
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This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.
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USP <788> Revisions And Why Packaging Matters More Than Ever
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Article | By Victoria Morgan, West Pharmaceutical Services, Inc.
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Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.
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Understanding Ethylene Oxide Residual Behavior
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Application Note | By Leonard Harris, Eurofins
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EtO sterilization leaves residuals that can delay device release and create compliance risk. Learn what drives absorption and desorption across materials, geometry, and process conditions under ISO 10993-7.
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