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iso-13485-certification
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Prepare and structurally review ISO 13485 QMS scope, controlled documentation, and local evidence manifests. Use for ISO 13485 certification-readiness documentation or for separating related FDA QMSR, MDSAP, and EU MDR/IVDR evidence boundar
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iso-13485-certification
skill:k-dense-ai/scientific-agent-skills/iso-13485-certification · published by k-dense-ai · source repository