iso-standards-compliance-checker
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
npx skills add a5c-ai/babysitter --skill iso-standards-compliance-checker --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# ISO Standards Compliance Checker Skill ## Purpose The ISO Standards Compliance Checker Skill verifies medical device compliance with applicable ISO and IEC standards, generating compliance checklists, gap analyses, and evidence mapping for quality management and regulatory submissions. ## Capabilities - Standards applicability determination - Compliance checklist generation - Gap analysis against standard clauses - Evidence mapping to requirements - Harmonized standards cross-reference - Declaration of Conformity assistance - Audit preparation support - Non-conformance tracking - Corrective action recommendations - Standards version comparison - Multi-standard compliance matrices ## Usage Guidelines ### When to Use - Implementing quality management systems - Preparing for certification audits - Conducting internal compliance reviews - Supporting regulatory submissions ### Prerequisites - Device type and intended use defined - Applicable regulatory pathways identified - Quality management system documentation available - Design and development records accessible ### Best Practices - Identify all applicable standards early in development - Maintain current knowledge of standards re
- Purpose
- Capabilities
- Usage Guidelines
- When to Use
- Prerequisites
- Best Practices
- Process Integration
- Dependencies
- Configuration
- Output Artifacts
- Quality Criteria
What does the iso-standards-compliance-checker skill do?
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
How do I install it?
Run `npx skills add a5c-ai/babysitter --skill iso-standards-compliance-checker --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From a5c-ai/babysitter, a repository with 1,642 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.