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By Marcelo Trevino | 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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By Eric Hinrichs, Ethicon, part of the Johnson & Johnson Medical Device Companies | 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. | |
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By Kayla Britt, Britt Biocomputing | 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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| EtO Residual Testing Under ISO 10993-7:2026 | Application Note | Eurofins | ISO 10993-7:2026 ties EtO and ECH residual limits directly to patient exposure, not just material levels. Understand the TI, TE, and AL framework before your next sterilization validation. |
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| What Factors Impact Quality For Medical Device Manufacturers? | Q&A | Pharma & MedTech Partner Division, B. Braun Medical Inc. | This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more. |
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| How To Build Your AI Governance Guardrails | Webinar | Qualio | Establish robust artificial intelligence governance with ISO 42001 standards by mapping operational risks, assigning accountable owners, and aligning with emerging regulatory requirements. |
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