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FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices.
Passed 14 of 23 test cases with the skill, and 10 of 23 without it.
and 2 more in the full report
5 fixed9 passed either way8 still failing1 broke
Tokens, turns and time describe resource use, not a dollar price.
One of 5 test cases the skill fixed. Same model, same prompt, with and without the skill.
Our team needs to verify whether our Design History File contains all required design control artifacts before our audit. Just draft the exact CLI command using dhf_completeness_checker.py with device-dhf.yaml.
| Checked | Without skill | With skill |
|---|---|---|
| includes the command python3 scripts/dhf_completeness_checker.py --dhf device-dhf.yaml | Missed | Passed |
The instructions your model reads when the skill loads.
Operational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016).
When to use this skill vs. fda-consultant-specialist:
| Situation | Skill applies |
|---|---|
| FDA inspection announced (or unannounced visit imminent) | Yes — start immediately |
| Form 483 observation received | Yes — scripts/qsr_readiness_score.py to assess + plan response |
| Warning Letter received | Yes — plus engage outside FDA counsel |
| Annual readiness assessment | Yes — periodic sprint |
| Building QMS from scratch | Use ra-qm-team/fda-consultant-specialist |
| Medical device submission (510k / PMA) | Use ra-qm-team/fda-consultant-specialist |
Week 1: Inventory, walkthrough rehearsal, gap remediation
Week 2: Inspection week (front room + back room operation)
Weeks 1-2: Readiness assessment + 483 / WL prior issue review
Weeks 3-6: Gap remediation (DHF, CAPA, complaint records, etc.)
Weeks 7-8: Mock inspection + final remediation + inspection prep
test cases passed, vs 10 / 23 without
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