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Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit…
Install Medical Qms Tools
$ npx skills add DrugClaw/DrugClaw --skill medical-qms-tools -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install DrugClaw/DrugClaw medical-qms-tools --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/DrugClaw/DrugClaw.git skills-src && mkdir -p .claude/skills && cp -r skills-src/skills/medical/medical-qms-tools .claude/skills/medical-qms-tools && 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 "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .claude/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-toolsType 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 DrugClaw/DrugClaw --skill medical-qms-tools -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install DrugClaw/DrugClaw medical-qms-tools --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/DrugClaw/DrugClaw.git skills-src && mkdir -p .agents/skills && cp -r skills-src/skills/medical/medical-qms-tools .agents/skills/medical-qms-tools && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .agents/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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 DrugClaw/DrugClaw --skill medical-qms-tools -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install DrugClaw/DrugClaw medical-qms-tools --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/DrugClaw/DrugClaw.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/skills/medical/medical-qms-tools .cursor/skills/medical-qms-tools && 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 "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .cursor/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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/DrugClaw/DrugClaw.git --path skills/medical/medical-qms-tools--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 DrugClaw/DrugClaw --skill medical-qms-tools -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install DrugClaw/DrugClaw medical-qms-tools --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/DrugClaw/DrugClaw.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/skills/medical/medical-qms-tools .gemini/skills/medical-qms-tools && 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 "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .gemini/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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 DrugClaw/DrugClaw medical-qms-toolsInstalls 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 DrugClaw/DrugClaw --skill medical-qms-tools -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/DrugClaw/DrugClaw.git skills-src && mkdir -p .github/skills && cp -r skills-src/skills/medical/medical-qms-tools .github/skills/medical-qms-tools && 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 "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .github/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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 DrugClaw/DrugClaw --skill medical-qms-tools -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install DrugClaw/DrugClaw medical-qms-tools --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/DrugClaw/DrugClaw.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/skills/medical/medical-qms-tools .opencode/skills/medical-qms-tools && 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 "medical-qms-tools" agent skill from https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools into .opencode/skills/medical-qms-tools/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "medical-qms-tools", 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
medical-qms-tools- GitHub stars
- 126
- Token cost
- ~682 tokens
- SKILL.md length
- 278 words
- Files
- 1
- Skills in repo
- 25
- Repo updated
- First seen
- Licence
- Apache-2.0
At a glance
Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit…
- Works in 5 steps: Treat this as documentation and process… → Ask what standard, jurisdiction, and… → Distinguish mandatory procedures from… → …
- The user asks to plan
- SKILL.md covers Working Rules, Core Workflow, Key Surfaces To Cover and Output Expectations, plus 1 more section
- Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md
What it does
Medical Qms Tools is an agent skill from DrugClaw/DrugClaw. Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit preparation. Use when the user asks to plan, review, or gap-assess medical-device or diagnostic quality documentation without asking for legal determinations or regulatory guarantees.
Its SKILL.md is about 680 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, covering Audit readiness. The repository describes itself as: 💊 AI Research Assistant for Accelerated Drug Discovery. 🦞. The licence is Apache-2.0.
When your agent uses it
- The user asks to plan
- Gap-assess medical-device
- Diagnostic quality documentation without asking for legal determinations
- Regulatory guarantees
Example prompts
- “/medical-qms-tools”
Workflow steps
5 steps, taken from the first numbered list in SKILL.md.
- Treat this as documentation and process support, not legal or certification advice.
- Ask what standard, jurisdiction, and product class the user is targeting before drafting requirements.
- Distinguish mandatory procedures from organization-specific implementations.
- Preserve traceability: requirement, procedure, record, owner, revision, and evidence.
- Flag missing risk-management and post-market processes explicitly.
What it can do on your machine
Read from SKILL.md and the folder at commit 960a6e0. 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
Medical Qms Tools loads about 682 tokens when it runs. Until then it costs about 99 tokens; SKILL.md has 278 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 DrugClaw/DrugClaw at commit 960a6e0, republished under its Apache-2.0 licence (© DrugClaw). 278 words, ~682 tokens.
Download SKILL.mdSave it as
.claude/skills/medical-qms-tools/SKILL.md (or your agent's skills folder).- name
- medical-qms-tools
- description
- Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit preparation. Use when the user asks to plan, review, or gap-assess medical-device or diagnostic quality documentation without asking for legal determinations or regulatory guarantees.
Medical QMS Tools
Use this skill for structured quality-system documentation work in regulated medical settings.
Typical triggers:
- gap-assess existing QMS documentation
- prepare or review Quality Manual, SOP, CAPA, complaint, audit, or training records
- map documents to ISO 13485 or FDA QMSR requirements
- define traceability across design inputs, verification, validation, and risk controls
- prepare audit-readiness checklists for device or diagnostic programs
Working Rules
- Treat this as documentation and process support, not legal or certification advice.
- Ask what standard, jurisdiction, and product class the user is targeting before drafting requirements.
- Distinguish mandatory procedures from organization-specific implementations.
- Preserve traceability: requirement, procedure, record, owner, revision, and evidence.
- Flag missing risk-management and post-market processes explicitly.
Core Workflow
- Inventory current documents and records.
- Build a clause-to-document matrix.
- Mark each item as present, partial, missing, or out of date.
- Prioritize critical gaps first:
- document control
- training and competence
- CAPA
- complaint handling
- supplier controls
- design controls
- risk management
- Draft remediation plan with owners, dependencies, and evidence artifacts.
Key Surfaces To Cover
Always check whether the user has adequate documentation for:
- scope and Quality Manual
- document and record control
- management review
- training and competence
- design and development planning
- design inputs, outputs, verification, validation, and transfer
- supplier qualification and purchasing controls
- production and process validation where relevant
- traceability and labeling
- complaint handling and vigilance
- CAPA and internal audit
- risk management linkage to design and post-market feedback
Output Expectations
Good outputs usually include:
- clause or requirement matrix
- missing-document list
- prioritized remediation plan
- draft document skeletons or SOP outlines
- audit-readiness checklist
Related Skills
For clinical-study protocols and reporting workflows, activate clinical-research-tools.
For medical datasets and operational analysis artifacts, activate medical-data-tools.
© DrugClaw, Apache-2.0. 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/medical/medical-qms-tools of DrugClaw/DrugClaw.
Open the folder on GitHubat commit 960a6e0
Compare with similar skills
Medical Qms Tools 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 |
|---|---|---|---|---|---|---|
| Medical Qms Tools this skillDrugClaw/DrugClaw | 126 | — | ~682 | Automated safety check: Pass | Apache-2.0 | |
| HIPAA Safe Harbor Coverage Auditmaziyarpanahi/openmed | 5.5k | — | ~1.7k | Automated safety check: Pass | Apache-2.0 | |
| ISO Standards Readiness EvidenceK-Dense-AI/scientific-agent-skills | 48k | 1 repos | ~4.6k | Automated safety check: Notes | MIT | |
| Iso42001Sushegaad/Claude-Skills-Governance-Risk-and-Compliance | 946 | 1 repos | ~3.7k | Automated safety check: Pass | MIT | |
| Fleet Triagegoogle-labs-code/jules-sdk | 137 | — | ~1.2k | Automated safety check: Pass | Apache-2.0 | |
| PCI DSS Compliancewshobson/agents | 40k | 11 repos | ~1.9k | Automated safety check: Pass | MIT |
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Related
Categories
Questions about Medical Qms Tools
What does Medical Qms Tools do?
Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit…. Medical Qms Tools is an agent skill from DrugClaw/DrugClaw. Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit preparation.
When should I use Medical Qms Tools?
Medical Qms Tools fits situations like: the user asks to plan; gap-assess medical-device; diagnostic quality documentation without asking for legal determinations; regulatory guarantees.
How do I install Medical Qms Tools in Claude Code?
Run `npx skills add DrugClaw/DrugClaw --skill medical-qms-tools -a claude-code`. Or copy the skill folder (skills/medical/medical-qms-tools in DrugClaw/DrugClaw) into .claude/skills/medical-qms-tools in your project. Claude Code loads it when a task matches its description.
How do I install Medical Qms Tools in Codex?
Run `npx skills add DrugClaw/DrugClaw --skill medical-qms-tools -a codex`. Or copy the skill folder (skills/medical/medical-qms-tools in DrugClaw/DrugClaw) into .agents/skills/medical-qms-tools in your project. Codex loads it when a task matches its description.
Can I use Medical Qms Tools 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 DrugClaw/DrugClaw --skill medical-qms-tools -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/medical-qms-tools, .gemini/skills/medical-qms-tools, .github/skills/medical-qms-tools and .opencode/skills/medical-qms-tools in your project.
What does Medical Qms Tools need to run?
SKILL.md names no scripts, command-line tools or credentials: Medical Qms Tools is instructions for the agent only.
Does Medical Qms Tools 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 Medical Qms Tools 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 Medical Qms Tools use?
Medical Qms Tools is published under the Apache-2.0 licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Medical Qms Tools use?
About 682 tokens (SKILL.md is roughly 2.7k 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 Medical Qms Tools?
Skills that share tags, products or a category with Medical Qms Tools: HIPAA Safe Harbor Coverage Audit (maziyarpanahi/openmed, 5.5k stars), ISO Standards Readiness Evidence (K-Dense-AI/scientific-agent-skills, 48k stars), Iso42001 (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars) and Fleet Triage (google-labs-code/jules-sdk, 137 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Medical Qms Tools?
DrugClaw (a GitHub organization) maintains it in DrugClaw/DrugClaw, which has 126 GitHub stars. The repository holds 25 skills in this directory. The repository was last updated on March 23, 2026.
Source: DrugClaw/DrugClaw on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.