Production Python tools for RA/QM skills — 11 scripts

[alirezarezvani]

Summary

Develop production-ready Python CLI tools for the 12 Regulatory Affairs & Quality Management skills. Most currently have placeholder or basic scripts.

Skills Needing Tools

1. regulatory-affairs-head — Regulatory pathway analyzer
2. quality-manager-qmr — QMS effectiveness monitor
3. quality-manager-qms-iso13485 — QMS compliance checker
4. capa-officer — CAPA tracker, root cause analyzer
5. quality-documentation-manager — Document version control
6. risk-management-specialist — Risk register manager, FMEA calculator
7. information-security-manager-iso27001 — ISMS compliance scanner
8. mdr-745-specialist — MDR compliance checker
9. fda-consultant-specialist — FDA submission packager
10. qms-audit-expert — Audit planner, finding tracker
11. isms-audit-expert — ISMS audit planner

Requirements

• Each script must be standalone (Python stdlib where possible)
• Include CLI argument parsing (argparse)
• JSON output support for automation
• Tested with sample data

Acceptance Criteria

• 11 production-ready Python scripts
• Each tested and documented
• SKILL.md files updated to reference new scripts