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Fewer, deeper pieces with real worked reasoning. Every article carries its jurisdiction, governing references, publication and review dates, a reviewer and a content status, and is reviewed on a schedule. Search works in your browser; nothing you type leaves this site.
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- Biological and clinical evaluation · Standards explainer ISO 10993-1:2025: how endpoint selection changes under the sixth edition The sixth edition reframes biological evaluation as a risk-management activity rather than a test programme. That changes how endpoints are selected, how exposure is counted and what a plan has to say before any sample reaches a laboratory. This article works through the changes with the logic a reviewer will apply.
- Biological and clinical evaluation · Technical method Toxicological risk assessment under ISO 10993-17:2023: a worked structure A toxicological risk assessment is where biological evaluations most often succeed quietly or fail loudly. This article sets out the structure of a TRA under the 2023 edition, step by step, with what a reviewer checks at each one and the shortcuts that produce deficiency letters.
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In preparation
Published at one article per fortnight, each carrying the governance header above and reviewed on a schedule. Next in the queue:
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- IEC 60601-1 applicability: building the collateral and particular standards matrix
- AI-enabled devices in the EU: MDR/IVDR plus the AI Act after the Digital Omnibus