Tax Law Research
Serein-81/financial_rag
Searches current Chinese tax laws, rates and policy changes with Tavily web search, prioritizing government sources and flagging outdated or conflicting results.
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820.
Install Fda Medtech Compliance Auditor
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditor --agent claude-codeProject scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .claude/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.
Claude Code skills documentation · loads skills from .claude/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .claude/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.Claude Code copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$skill-installer install https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditorType this inside Codex. $skill-installer <name> installs a curated skill from openai/skills. The installer writes to $CODEX_HOME/skills (default ~/.codex/skills). Restart Codex if the skill does not show up.
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditor --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .agents/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .agents/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.Codex copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditor --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .cursor/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.cursor/skills/ instead of .cursor/skills for a personal install.
Cursor skills documentation · loads skills from .cursor/skills/, .agents/skills/, .claude/skills/, .codex/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .cursor/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.Cursor copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gemini skills install https://github.com/sickn33/agentic-awesome-skills.git --path skills/fda-medtech-compliance-auditor--scope user (default) or --scope workspace; --path is the subfolder of the repo that holds the skill; --consent skips the security confirmation prompt.
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditor --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .gemini/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.gemini/skills/ instead of .gemini/skills for a personal install, then run /skills reload.
Gemini CLI skills documentation · loads skills from .gemini/skills/, .agents/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .gemini/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.Gemini CLI copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditorInstalls for Copilot at project scope by default; add --scope user for a personal install. Preview a skill first with gh skill preview. Needs GitHub CLI 2.90.0 or later (public preview).
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .github/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.copilot/skills/ instead of .github/skills for a personal install. Commit .github/skills so cloud agent and code review can use it.
GitHub Copilot skills documentation · loads skills from .github/skills/, .claude/skills/, .agents/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .github/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.GitHub Copilot copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install sickn33/agentic-awesome-skills fda-medtech-compliance-auditor --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/sickn33/agentic-awesome-skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/skills/fda-medtech-compliance-auditor .opencode/skills/fda-medtech-compliance-auditor && rm -rf skills-srcUse ~/.config/opencode/skills/ instead of .opencode/skills for a personal install.
OpenCode skills documentation · loads skills from .opencode/skills/, .claude/skills/, .agents/skills/
Install the "fda-medtech-compliance-auditor" agent skill from https://github.com/sickn33/agentic-awesome-skills/tree/main/skills/fda-medtech-compliance-auditor into .opencode/skills/fda-medtech-compliance-auditor/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-medtech-compliance-auditor", then confirm the skill loads.OpenCode copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
Facts
- Skill name
fda-medtech-compliance-auditor- GitHub stars
- 47k
- Used in
- 2 other repos
- Token cost
- ~818 tokens
- SKILL.md length
- 324 words
- Files
- 1
- Skills in repo
- 1,497
- Repo updated
- First seen
- Licence
- MIT
At a glance
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820.
- Works in 4 steps: Activate the Skill: Mention… → Specify the Standard: State whether the… → Receive Findings: The AI outputs… → …
- Legal & Compliance work in your project
- SKILL.md covers Overview, When to Use This Skill, How It Works and Examples, plus 2 more sections
- Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md
What it does
Fda Medtech Compliance Auditor is an agent skill from sickn33/agentic-awesome-skills. Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
Its SKILL.md is about 820 tokens, which your agent loads only when the skill is triggered. It is a single SKILL.md file with no bundled scripts.
It sits in Legal & Compliance. The repository describes itself as: AAS Core is the local, agent-first control plane for complete catalog discovery, agent-owned selection, stack validation, and planning, backed by 2,400+ agentic skills. Includes… The licence is MIT.
When your agent uses it
- Legal & Compliance work in your project
Example prompts
- “/fda-medtech-compliance-auditor”
Workflow steps
4 steps, taken from the first numbered list in SKILL.md.
- Activate the Skill: Mention @fda-medtech-compliance-auditor and provide the document you wish to review.
- Specify the Standard: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.
- Receive Findings: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with…
- Correction Guidance: Get actionable steps to resolve each finding and strengthen your audit readiness.
What it can do on your machine
Read from SKILL.md and the folder at commit b84d35a. It shows what the files ask for, not the result of running them.
Tool permissions
Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.
From allowed-tools in the SKILL.md frontmatter.
Runs code
No scripts in the folder and no shell commands in SKILL.md.
From the folder's file list and the shell code blocks in SKILL.md.
Network
No URLs in SKILL.md.
From URLs in SKILL.md, links to its own repository left out.
Credentials
Names no API keys, tokens, secrets or passwords.
From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.
Context cost
Fda Medtech Compliance Auditor loads about 818 tokens when it runs. Until then it costs about 44 tokens; SKILL.md has 324 words of instructions outside code blocks.
Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.
Safety
Auto-check passed
The automated check found no risky patterns in SKILL.md.
Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.
SKILL.md
The full file from sickn33/agentic-awesome-skills at commit b84d35a, republished under its MIT licence (© sickn33). 324 words, ~818 tokens.
Download SKILL.mdSave it as
.claude/skills/fda-medtech-compliance-auditor/SKILL.md (or your agent's skills folder).- name
- fda-medtech-compliance-auditor
- description
- Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
- risk
- none
- source
- community
- date_added
- 2026-09-04
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
- Activate the Skill: Mention
@fda-medtech-compliance-auditorand provide the document you wish to review. - Specify the Standard: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.
- Receive Findings: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.
- 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.
© sickn33, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
Just SKILL.md in skills/fda-medtech-compliance-auditor of sickn33/agentic-awesome-skills.
Open the folder on GitHubat commit b84d35a
Used in 2 other repositories
We found 11 copies of this SKILL.md (exact, near-identical or edited) in other folders, from 2 other GitHub owners. This page covers the copy in sickn33/agentic-awesome-skills, which our catalogue first saw on October 7, 2026.
- lingxling/awesome-skills-cnantigravity-awesome-skills/skills/fda-medtech-compliance-auditorantigravity-awesome-skills/plugins/agentic-awesome-skills/skills/fda-medtech-compliance-auditor+1 more
- henryalouf/ruflow.agents/skills/fda-medtech-compliance-auditor.agents/skills/antigravity-awesome-skills/skills/fda-medtech-compliance-auditor+4 more
Compare with similar skills
Fda Medtech Compliance Auditor next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.
| Skill | Stars | Used in | Tokens | Auto-check | Licence | Repo updated |
|---|---|---|---|---|---|---|
| Fda Medtech Compliance Auditor this skillsickn33/agentic-awesome-skills | 47k | 2 repos | ~818 | Automated safety check: Pass | MIT | |
| Tax Law ResearchSerein-81/financial_rag | 148 | — | ~997 | Automated safety check: Notes | None | |
| Policy Crawl PipelineSerein-81/financial_rag | 148 | — | ~1.4k | Automated safety check: Notes | None | |
| CsrdSushegaad/Claude-Skills-Governance-Risk-and-Compliance | 946 | 1 repos | ~4k | Automated safety check: Pass | MIT | |
| Quality Manager Qmrborghei/Claude-Skills | 891 | — | ~5.8k | Automated safety check: Pass | MIT | |
| Negotiation Playbookrevfactory/harness-100 | 1.3k | — | ~1.3k | Automated safety check: Pass | Apache-2.0 |
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Related
Categories
Questions about Fda Medtech Compliance Auditor
What does Fda Medtech Compliance Auditor do?
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Fda Medtech Compliance Auditor is an agent skill from sickn33/agentic-awesome-skills. Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820.
When should I use Fda Medtech Compliance Auditor?
Fda Medtech Compliance Auditor fits situations like: legal & Compliance work in your project.
How do I install Fda Medtech Compliance Auditor in Claude Code?
Run `npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a claude-code`. Or copy the skill folder (skills/fda-medtech-compliance-auditor in sickn33/agentic-awesome-skills) into .claude/skills/fda-medtech-compliance-auditor in your project. Claude Code loads it when a task matches its description.
How do I install Fda Medtech Compliance Auditor in Codex?
Run `npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a codex`. Or copy the skill folder (skills/fda-medtech-compliance-auditor in sickn33/agentic-awesome-skills) into .agents/skills/fda-medtech-compliance-auditor in your project. Codex loads it when a task matches its description.
Can I use Fda Medtech Compliance Auditor in Cursor, Gemini CLI or GitHub Copilot?
Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/fda-medtech-compliance-auditor, .gemini/skills/fda-medtech-compliance-auditor, .github/skills/fda-medtech-compliance-auditor and .opencode/skills/fda-medtech-compliance-auditor in your project.
What does Fda Medtech Compliance Auditor need to run?
SKILL.md names no scripts, command-line tools or credentials: Fda Medtech Compliance Auditor is instructions for the agent only.
Does Fda Medtech Compliance Auditor access the network?
SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.
Is Fda Medtech Compliance Auditor safe to install?
Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.
What licence does Fda Medtech Compliance Auditor use?
Fda Medtech Compliance Auditor is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Fda Medtech Compliance Auditor use?
About 818 tokens (SKILL.md is roughly 3.3k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full.
What are the alternatives to Fda Medtech Compliance Auditor?
Skills that share tags, products or a category with Fda Medtech Compliance Auditor: Tax Law Research (Serein-81/financial_rag, 148 stars), Policy Crawl Pipeline (Serein-81/financial_rag, 148 stars), Csrd (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars) and Quality Manager Qmr (borghei/Claude-Skills, 891 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Fda Medtech Compliance Auditor?
sickn33 (a GitHub user) maintains it in sickn33/agentic-awesome-skills, which has 47,405 GitHub stars. The repository holds 1,497 skills in this directory. The repository was last updated on October 9, 2026.
Source: sickn33/agentic-awesome-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.