快速判断
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
适合任务
- 把重复任务整理成可复用的 AI 操作流程。
- 让 AI 在特定场景下按统一规范执行。
- 为团队或个人工作流提供可复制的任务说明。
输入与输出
输入：任务目标、上下文材料、文件路径、约束条件或需要处理的内容。
输出：按 Skill 说明生成的文档、代码、检查结果、计划、建议或操作步骤。
示例任务
- 使用 fda-medtech-compliance-auditor 帮我处理当前任务，并说明执行前需要确认的输入。
- 根据 fda-medtech-compliance-auditor 的说明，给我一个安全的使用步骤清单。
安装方式
- 下载本站提供的 Skill ZIP 并解压。
- 把解压后的 Skill 目录放入当前 AI 工具支持的
skills目录。 - 如需在线查看原始内容，可打开 GitHub 的
SKILL.md。
风险边界
使用前请检查权限、外部依赖和要处理的数据类型。不要把密码、密钥、身份信息或敏感客户资料交给未经确认的 Skill。
SKILL.md 文档介绍
FDA MedTech Compliance Auditor
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).
When to Use This Skill
- 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.
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: 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
- ✅ 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.
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.