Regulatory & Compliance CAPAQMSMedical Device

CAPA Officer

CAPA system management for medical device quality management.

$skillfish add ~skills/capa-officer

Real Examples Get Started Models & Context

Real Conversations

See how the CAPA Officer skill responds to actual requests. These are representative examples of what your AI agent will produce.

You

We received a complaint from a hospital customer — our infusion pump software showed an incorrect drug dosage calculation in 3 patient cases. No adverse events reported, but we need to open a CAPA. What does the CAPA need to include under ISO 13485?

Agent

CAPA Initiation — Infusion Pump Dosage Calculation Error

Under ISO 13485:2016 §8.5.2 (Corrective Action), your CAPA must include:

1. Problem Description

Device: [Model/SW version]
Complaint reference: [NCR number]
Description: Incorrect dosage calculation displayed in 3 patient cases at [Customer]
Potential patient impact: Risk of under/overdose — classify as Serious Injury potential under MDR Article 2(65)
Regulatory reportable? Assess against MDR 2017/745 Art. 87 — if SW failure could have caused serious patient deterioration, report within 15 days

2. Immediate Containment Actions

Notify affected customer(s) with interim workaround instructions
Identify all devices/SW versions with this build in field (traceability review)
Issue Field Safety Notice if containment requires action by users
Quarantine affected SW version from further distribution

3. Root Cause Analysis (required by §8.5.2) Use Ishikawa + 5 Whys. Categories to investigate:

Software requirements specification (was the calculation logic specified correctly?)
Verification testing (was this calculation tested? with what inputs?)
Validation (did clinical use-case testing cover edge cases?)

4. Corrective Action Plan

Action	Owner	Target Date
Root cause confirmed via code review	SW Engineering Lead	Day +5
Software patch developed + unit tested	Dev Team	Day +15
Verification testing of fix	QA	Day +22
Clinical validation of updated calculation	Clinical Affairs	Day +30
SW update distributed to field	Regulatory/QA	Day +45

5. Effectiveness Check Define: "CAPA is effective when zero recurrence of dosage calculation errors is reported in 90-day post-deployment monitoring period."

6. Cross-References

Link to original complaint record
Link to risk management file (ISO 14971) — update risk assessment for this hazard
Link to design history file (DHF) — update SW requirements and test cases

You

We opened a CAPA 6 months ago for a labeling nonconformance — wrong storage temperature on IFU. The corrective action was to update the IFU and retrain the documentation team. How do I verify effectiveness for our upcoming ISO 13485 surveillance audit?

Agent

CAPA Effectiveness Verification — IFU Labeling Nonconformance

ISO 13485:2016 §8.5.2 requires you to review the effectiveness of corrective actions taken. Here's what your auditor will look for:

Effectiveness criteria (should have been defined at CAPA opening): If not defined earlier, document now:

"Effectiveness confirmed when: (1) updated IFU v2.x is distributed to all active devices in field, (2) zero labeling-related complaints received in 6-month monitoring window, (3) documentation team training records complete for all 8 staff."

Evidence to compile for audit:

Evidence	Document	Status
Updated IFU approved and released	Document Control — IFU v2.x release record	Verify
Distribution to customers	DHR / shipping records showing v2.x IFU with all shipments post-CAPA	Verify
Training completion	Training matrix — all 8 documentation team members signed off	Verify
Complaint monitoring	Complaint log — filter for IFU/labeling category, 6-month window	Verify
No recurrence	Search NCR log for any labeling nonconformances after CAPA date	Must confirm

If any gaps exist before the audit:

Missing distribution records → Contact customers for confirmation; document in CAPA file
Recurrence found → Do NOT close CAPA; escalate to Quality Manager, reopen with extended scope

CAPA closure sign-off required from: Quality Manager Responsible (QMR) per §5.5.2

Auditor interview prep: Be ready to walk through the full CAPA timeline — opening, RCA evidence, action completion dates, and effectiveness data — without referring to notes.

Get Started

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Skills are designed for AI coding agents (Claude Code, Cursor, Windsurf) and IDE-based workflows where the agent can read files, run scripts, and act on your codebase. Web-based AI can use the knowledge and frameworks, but won't have tool access.

Models & Context

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Recommended Models

Best

Claude Opus 4 Claude Sonnet 4 GPT-4.1 Gemini 2.5 Pro Grok 3 Kimi K2

Good

Claude Haiku 4.5 GPT-4.1 mini Gemini 2.5 Flash Grok 3 mini

Larger models produce more detailed, production-ready outputs.

Context Window

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8K Skill only

32K+ Skill + conversation

100K+ Skill + references + codebase

All current frontier models (Claude, GPT, Gemini) support 100K+ context. Use the full window for complex multi-service work.

Pro tips for best results

1

Be specific

Include numbers — users, budget, RPS — so the skill can size the architecture.

2

Share constraints

Compliance needs, team size, and existing stack all improve the output.

3

Iterate

Start with a high-level design, then ask follow-ups for IaC, cost analysis, or security review.

4

Combine skills

Pair with companion skills below for end-to-end coverage.

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