Fda Medtech Compliance Auditor V2

Use this section as the trigger filter. It should make the activation boundary explicit before the operator loads files, runs commands, or opens a pull request.

• Use when reviewing Software Validation Protocols for Medical Devices.
• Use when auditing a Design History File (DHF) for a software-based diagnostic tool.
• Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records.
• Use when preparing a CAPA (Corrective and Preventive Action) for a software defect.
• Use when the request clearly matches the imported source intent: Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
• Use when the operator should preserve upstream workflow detail instead of rewriting the process from scratch.

Operating Table

Workflow

This workflow is intentionally editorial and operational at the same time. It keeps the imported source useful to the operator while still satisfying the public intake standards that feed the downstream enhancer flow.

1. Confirm the user goal, the scope of the imported workflow, and whether this skill is still the right router for the task.
2. Read the overview and provenance files before loading any copied upstream support files.
3. Load only the references, examples, prompts, or scripts that materially change the outcome for the current request.
4. Execute the upstream workflow while keeping provenance and source boundaries explicit in the working notes.
5. Validate the result against the upstream expectations and the evidence you can point to in the copied files.
6. Escalate or hand off to a related skill when the work moves out of this imported workflow's center of gravity.
7. Before merge or closure, record what was used, what changed, and what the reviewer still needs to verify.

Imported Workflow Notes

Imported: Overview

This skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management).

Imported: How It Works

1. Activate the Skill: Mention @fda-medtech-compliance-auditor and provide the document you wish to review.
2. Specify the Standard: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.
3. Receive Findings: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.
4. Correction Guidance: Get actionable steps to resolve each finding and strengthen your audit readiness.

Examples

Example 1: Ask for the upstream workflow directly

Use @fda-medtech-compliance-auditor-v2 to handle <task>. Start from the copied upstream workflow, load only the files that change the outcome, and keep provenance visible in the answer.

Explanation: This is the safest starting point when the operator needs the imported workflow, but not the entire repository.

Example 2: Ask for a provenance-grounded review

Review @fda-medtech-compliance-auditor-v2 against EXTERNAL_SOURCE.json and ORIGIN.md, then explain which copied upstream files you would load first and why.

Explanation: Use this before review or troubleshooting when you need a precise, auditable explanation of origin and file selection.

Example 3: Narrow the copied support files before execution

Use @fda-medtech-compliance-auditor-v2 for <task>. Load only the copied references, examples, or scripts that change the outcome, and name the files explicitly before proceeding.

Explanation: This keeps the skill aligned with progressive disclosure instead of loading the whole copied package by default.

Example 4: Build a reviewer packet

Review @fda-medtech-compliance-auditor-v2 using the copied upstream files plus provenance, then summarize any gaps before merge.

Explanation: This is useful when the PR is waiting for human review and you want a repeatable audit packet.

Imported Usage Notes

Imported: Examples

Example 1: CAPA Root Cause Review

Scenario: A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining.

Finding:

FDA AUDIT FINDING
Severity: Major
Citation: 21 CFR 820.100(a)(2) / IEC 62304 Section 5.1

Analysis:
"Developer error" is a symptom, not a root cause. Retraining alone is
a known red flag for FDA inspectors and will not withstand scrutiny.
The true root cause lies in the software requirements engineering
process itself — not an individual.

Required Actions:
1. Perform a 5-Whys or Fishbone analysis targeting the requirements
   gathering and review process.
2. Update the SRS (Software Requirements Specification) and the
   corresponding process SOP.
3. Document an effectiveness check with a measurable criterion
   (e.g., zero requirements-related defects in next 3 releases).
4. Do not close the CAPA on retraining alone.

Best Practices

Treat the generated public skill as a reviewable packaging layer around the upstream repository. The goal is to keep provenance explicit and load only the copied source material that materially improves execution.

• ✅ Do: Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.
• ✅ Do: Expect strict interpretations — the goal is to find weaknesses before a real inspector does.
• ❌ Don't: Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.
• ❌ Don't: Assume "we tested it and it works" satisfies IEC 62304 software verification requirements.
• Keep the imported skill grounded in the upstream repository; do not invent steps that the source material cannot support.
• Prefer the smallest useful set of support files so the workflow stays auditable and fast to review.
• Keep provenance, source commit, and imported file paths visible in notes and PR descriptions.

Imported Operating Notes

Imported: Best Practices

• ✅ Do: Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.
• ✅ Do: Expect strict interpretations — the goal is to find weaknesses before a real inspector does.
• ❌ Don't: Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.
• ❌ Don't: Assume "we tested it and it works" satisfies IEC 62304 software verification requirements.

Troubleshooting

Problem: The operator skipped the imported context and answered too generically

Symptoms: The result ignores the upstream workflow in plugins/antigravity-awesome-skills/skills/fda-medtech-compliance-auditor, fails to mention provenance, or does not use any copied source files at all. Solution: Re-open EXTERNAL_SOURCE.json, ORIGIN.md, and the most relevant copied upstream files. Load only the files that materially change the answer, then restate the provenance before continuing.

Problem: The imported workflow feels incomplete during review

Symptoms: Reviewers can see the generated SKILL.md, but they cannot quickly tell which references, examples, or scripts matter for the current task. Solution: Point at the exact copied references, examples, scripts, or assets that justify the path you took. If the gap is still real, record it in the PR instead of hiding it.

Problem: The task drifted into a different specialization

Symptoms: The imported skill starts in the right place, but the work turns into debugging, architecture, design, security, or release orchestration that a native skill handles better. Solution: Use the related skills section to hand off deliberately. Keep the imported provenance visible so the next skill inherits the right context instead of starting blind.

Related Skills

• @error-debugging-multi-agent-review-v2 - Use when the work is better handled by that native specialization after this imported skill establishes context.
• @error-detective-v2 - Use when the work is better handled by that native specialization after this imported skill establishes context.
• @error-diagnostics-error-analysis-v2 - Use when the work is better handled by that native specialization after this imported skill establishes context.
• @error-diagnostics-error-trace-v2 - Use when the work is better handled by that native specialization after this imported skill establishes context.

Additional Resources

Use this support matrix and the linked files below as the operator packet for this imported skill. They should reflect real copied source material, not generic scaffolding.

Imported Reference Notes

Imported: Limitations

• Use this skill only when the task clearly matches the scope described above.
• Do not treat the output as a substitute for environment-specific validation, testing, or expert review.
• Stop and ask for clarification if required inputs, permissions, safety boundaries, or success criteria are missing.