iso-13485-certification
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 boundaries; not for legal applicability, compliance, or certificati
By k-dense-ai · 918 installs
npx skills add k-dense-ai/scientific-agent-skills --skill iso-13485-certification