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 certification decisions.
73
Quality
92%
Does it follow best practices?
Run evals on this skill
Adds up to 20 points to the overall score
View guide
Securityby
Passed
No findings from the security scan
No security issues found
Scanned
- Repository
- K-Dense-AI/scientific-agent-skills
- Commit
757b63b
- Audited
- Security analysis
Is this your skill?
If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.