Paper to Chinese Patent Drafter
Yuan1z0825/nature-skills
Drafts Chinese invention patent applications and technical disclosures from research papers or inventor materials, tying each claim feature to source evidence.
FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices.
Install Fda Qsr Audit Prep
$ npx skills add borghei/Claude-Skills --skill fda-qsr-audit-prep -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install borghei/Claude-Skills fda-qsr-audit-prep --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/borghei/Claude-Skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .claude/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .claude/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prepType 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 borghei/Claude-Skills --skill fda-qsr-audit-prep -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install borghei/Claude-Skills fda-qsr-audit-prep --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .agents/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .agents/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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 borghei/Claude-Skills --skill fda-qsr-audit-prep -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install borghei/Claude-Skills fda-qsr-audit-prep --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .cursor/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .cursor/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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/borghei/Claude-Skills.git --path ra-qm-team/audit-prep/fda-qsr-audit-prep--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 borghei/Claude-Skills --skill fda-qsr-audit-prep -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install borghei/Claude-Skills fda-qsr-audit-prep --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .gemini/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .gemini/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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 borghei/Claude-Skills fda-qsr-audit-prepInstalls 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 borghei/Claude-Skills --skill fda-qsr-audit-prep -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .github/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .github/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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 borghei/Claude-Skills --skill fda-qsr-audit-prep -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install borghei/Claude-Skills fda-qsr-audit-prep --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/ra-qm-team/audit-prep/fda-qsr-audit-prep .opencode/skills/fda-qsr-audit-prep && 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-qsr-audit-prep" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/audit-prep/fda-qsr-audit-prep into .opencode/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", 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-qsr-audit-prep- GitHub stars
- 881
- Token cost
- ~1.9k tokens
- SKILL.md length
- 724 words
- Files
- 5 (incl. scripts, references)
- Skills in repo
- 349
- Repo updated
- First seen
- Licence
- MIT
At a glance
FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices.
- Works in 4 steps: Run readiness score: python3… → Check DHF completeness for in-scope… → Pick sprint length based on score +… → …
- An FDA inspection is announced
- SKILL.md covers When to use this skill, The audit-prep sprint at a…, QSR / QMSR key audit areas and Clarify First, plus 6 more sections
- Runs Python scripts from its folder; calls python3
What it does
Fda Qsr Audit Prep is an agent skill from borghei/Claude-Skills. FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.
Its SKILL.md is about 1.9k tokens, which your agent loads only when the skill is triggered. The skill folder holds 6 other files, including scripts and reference files (for example `references/483-warning-letter-prevention.md`, `references/fda-qsr-pre-inspection-checklist.md` and `scripts/dhf_completeness_checker.py`).
It sits in Legal & Compliance. The repository describes itself as: 385 AI skills, 77 expert agents, and 900 stdlib Python tools for every team: engineering, PM, marketing, C-level, compliance, business ops, research, and a LinkedIn toolkit… The licence is MIT.
When your agent uses it
- An FDA inspection is announced
- Preparing for the new QMSR (2026)
- A 483 / Warning Letter response is needed
Example prompts
- “/fda-qsr-audit-prep”
Requirements
- Python 3
Workflow steps
4 steps, taken from the first numbered list in SKILL.md.
- Run readiness score: python3 scripts/qsr_readiness_score.py --config qsr-controls.yaml
- Check DHF completeness for in-scope devices: python3 scripts/dhf_completeness_checker.py --dhf device-dhf.yaml
- Pick sprint length based on score + known issues
- Execute sprint per references/fda-qsr-pre-inspection-checklist.md
What it can do on your machine
Read from SKILL.md and the folder at commit 4a698e8. 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
Ships 2 files in scripts/ (Python), which the agent can run.
Shell commands in SKILL.md call:
python3
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 Qsr Audit Prep loads about 1.9k tokens when it runs, and up to ~7.2k if it reads all its reference files. Until then it costs about 60 tokens; SKILL.md has 724 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); the scripts in this folder are not scanned.
SKILL.md
The full file from borghei/Claude-Skills at commit 4a698e8, republished under its MIT licence (© borghei). 724 words, ~1,947 tokens.
Download SKILL.mdSave it as
.claude/skills/fda-qsr-audit-prep/SKILL.md (or your agent's skills folder). This skill also uses 4 other files; get the full folder from GitHub.- name
- fda-qsr-audit-prep
- description
- FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.
- license
- MIT + Commons Clause
- metadata.version
- 1.0.0
- metadata.author
- borghei
- metadata.category
- compliance
- metadata.domain
- ra-qm-team
- metadata.updated
- 2026-05-27
- metadata.tags
- fda, qsr, qmsr, 21-cfr-820, medical-devices, audit-prep, 483-response, warning-letter
FDA QSR / QMSR Audit Prep
Operational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016).
When to use this skill vs. fda-consultant-specialist:
- This skill: FDA inspection imminent OR 483/Warning Letter received; need sprint
- fda-consultant-specialist: building / maintaining QMS; multi-quarter
When to use this skill
| Situation | Skill applies |
|---|---|
| FDA inspection announced (or unannounced visit imminent) | Yes — start immediately |
| Form 483 observation received | Yes — scripts/qsr_readiness_score.py to assess + plan response |
| Warning Letter received | Yes — plus engage outside FDA counsel |
| Annual readiness assessment | Yes — periodic sprint |
| Building QMS from scratch | Use ra-qm-team/fda-consultant-specialist |
| Medical device submission (510k / PMA) | Use ra-qm-team/fda-consultant-specialist |
The audit-prep sprint at a glance
2-week sprint (announced inspection, mature QMS)
Week 1: Inventory, walkthrough rehearsal, gap remediation
Week 2: Inspection week (front room + back room operation)8-week sprint (gaps identified, scheduled inspection)
Weeks 1-2: Readiness assessment + 483 / WL prior issue review
Weeks 3-6: Gap remediation (DHF, CAPA, complaint records, etc.)
Weeks 7-8: Mock inspection + final remediation + inspection prepReactive: 483 / Warning Letter response
- 483: 15 business days to respond (then ongoing)
- Warning Letter: 15 business days to respond (then full corrective action plan)
- Approach: Acknowledge + investigate root cause + corrective action plan + commitment + evidenceQSR / QMSR key audit areas
| 21 CFR 820 Subpart | Topic | Audit focus |
|---|---|---|
| Subpart B | Quality system | Management responsibility, quality policy, planning |
| Subpart C | Design controls | Design history file (DHF), design reviews, V&V |
| Subpart D | Document controls | Document approval, change control, distribution |
| Subpart E | Purchasing controls | Supplier qualification, agreements, evaluations |
| Subpart F | Identification and traceability | Product ID, lot/batch traceability |
| Subpart G | Production and process controls | Process validation, environmental controls, equipment maintenance |
| Subpart H | Acceptance activities | Receiving, in-process, finished device acceptance |
| Subpart I | Nonconforming product | Identification, segregation, disposition |
| Subpart J | Corrective and preventive action (CAPA) | CAPA process, root cause analysis, effectiveness verification |
| Subpart K | Labeling and packaging | Label inspection, packaging validation |
| Subpart L | Handling, storage, distribution | Procedures, shelf-life, distribution records |
| Subpart M | Records | Device Master Record (DMR), Device History Record (DHR), QSR records |
| Subpart N | Servicing | Servicing procedures, complaint review |
| Subpart O | Statistical techniques | Sampling, statistical methods |
QMSR transition (effective Feb 2026): Harmonizes 21 CFR 820 with ISO 13485:2016. Adds requirements for risk management (ISO 14971), software lifecycle (IEC 62304), usability (IEC 62366).
Clarify First
Before running the audit-prep, confirm these inputs. If any is unknown or vague, ASK — do not assume:
- Trigger — announced inspection, Form 483 received, Warning Letter, or annual readiness (chooses between the sprint track and the reactive 15-day response track, and sets deadlines)
- Framework — legacy QSR (21 CFR 820) vs QMSR (ISO 13485-harmonized, effective Feb 2026) (changes which requirements and subparts apply)
- QMS maturity and known issues — mature vs gaps, plus prior 483/WL findings (picks the 2-week vs 8-week sprint)
Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the readiness assessment.
Show full SKILL.md (307 more words)Show less
Quick start
- Run readiness score:
python3 scripts/qsr_readiness_score.py --config qsr-controls.yaml - Check DHF completeness for in-scope devices:
python3 scripts/dhf_completeness_checker.py --dhf device-dhf.yaml - Pick sprint length based on score + known issues
- Execute sprint per references/fda-qsr-pre-inspection-checklist.md
Common FDA inspection findings (highest 483 / Warning Letter trigger)
- CAPA failures — root cause not addressed, ineffective corrective action
- Complaint handling — complaints not investigated, MDR (Medical Device Reporting) missed
- Design controls (Subpart C) — DHF incomplete, V&V gaps, no design reviews
- Process validation — processes not validated, validation stale
- Supplier controls — suppliers not qualified, agreements missing, evaluations skipped
- Document control — old procedures in use, no document approval evidence
- Management responsibility — no management review, no quality policy, no objectives
- Records (DHR) — incomplete records, missing lot traceability
See references/483-warning-letter-prevention.md for prevention patterns + response templates.
Inspection-week operations
Front room (where inspector works)
- Designated front room (conference room, not someone's office)
- Front-room lead (often Quality Manager) accompanies inspector all day
- All requests routed through front-room lead
- Inspector requests evidence; front-room asks back-room
Back room (where requests are fulfilled)
- Cross-functional team available
- Document retrieval, witness preparation, technical questions answered
- Inspector requests evidence; back-room delivers (filtered through front-room lead)
Daily debrief
- End of each inspection day: review what was inspected, observations, next-day topics
- Prepare overnight any evidence needed for next day
After inspection
- Form 483 review (if issued): consult with QA Lead + outside counsel
- 15 business days to respond
- Full corrective action plan
- Ongoing engagement with FDA office
Tooling
| Script | Purpose |
|---|---|
scripts/qsr_readiness_score.py | Score current QSR/QMSR state per subpart |
scripts/dhf_completeness_checker.py | Validate Design History File completeness per device |
References
- fda-qsr-pre-inspection-checklist.md — full pre-inspection punch list per subpart
- 483-warning-letter-prevention.md — common triggers + prevention + response patterns
Related skills
ra-qm-team/fda-consultant-specialist— deep FDA program (510k, PMA, QMSR build)ra-qm-team/quality-manager-qms-iso13485— ISO 13485 QMS (QMSR harmonized)ra-qm-team/risk-management-specialist— ISO 14971 (required for QMSR)ra-qm-team/capa-officer— CAPA process specialistra-qm-team/qms-audit-expert— internal/external QMS auditsra-qm-team/audit-prep/compliance-readiness— multi-framework readiness
© borghei, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
SKILL.md and 4 other files (scripts, references) in ra-qm-team/audit-prep/fda-qsr-audit-prep of borghei/Claude-Skills.
- SKILL.md
- references/483-warning-letter-prevention.md
- references/fda-qsr-pre-inspection-checklist.md
- scripts/dhf_completeness_checker.py
- scripts/qsr_readiness_score.py
Open the folder on GitHubat commit 4a698e8
Compare with similar skills
Fda Qsr Audit Prep 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 Qsr Audit Prep this skillborghei/Claude-Skills | 881 | — | ~1.9k | Automated safety check: Pass | MIT | |
| Paper to Chinese Patent DrafterYuan1z0825/nature-skills | 46k | 1 repos | ~1.1k | Automated safety check: Pass | Apache-2.0 | |
| C15tc15t/c15t | 1.9k | 1 repos | ~1.6k | Automated safety check: Pass | Apache-2.0 | |
| Contract Reviewevolsb/claude-legal-skill | 462 | 1 repos | ~3.6k | Automated safety check: Pass | MIT | |
| Legal Clinic Client Intakeanthropics/claude-for-legal | 9.6k | 3 repos | ~3.2k | Automated safety check: Pass | Apache-2.0 | |
| Paper To Cn Patentsnipp-zha/Paper-to-patent-Skill | 105 | 1 repos | ~959 | Automated safety check: Pass | None |
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Categories
Questions about Fda Qsr Audit Prep
What does Fda Qsr Audit Prep do?
FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Fda Qsr Audit Prep is an agent skill from borghei/Claude-Skills. FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices.
When should I use Fda Qsr Audit Prep?
Fda Qsr Audit Prep fits situations like: an FDA inspection is announced; preparing for the new QMSR (2026); A 483 / Warning Letter response is needed.
How do I install Fda Qsr Audit Prep in Claude Code?
Run `npx skills add borghei/Claude-Skills --skill fda-qsr-audit-prep -a claude-code`. Or copy the skill folder (ra-qm-team/audit-prep/fda-qsr-audit-prep in borghei/Claude-Skills) into .claude/skills/fda-qsr-audit-prep in your project. Claude Code loads it when a task matches its description.
How do I install Fda Qsr Audit Prep in Codex?
Run `npx skills add borghei/Claude-Skills --skill fda-qsr-audit-prep -a codex`. Or copy the skill folder (ra-qm-team/audit-prep/fda-qsr-audit-prep in borghei/Claude-Skills) into .agents/skills/fda-qsr-audit-prep in your project. Codex loads it when a task matches its description.
Can I use Fda Qsr Audit Prep 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 borghei/Claude-Skills --skill fda-qsr-audit-prep -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-qsr-audit-prep, .gemini/skills/fda-qsr-audit-prep, .github/skills/fda-qsr-audit-prep and .opencode/skills/fda-qsr-audit-prep in your project.
What does Fda Qsr Audit Prep need to run?
Going by SKILL.md and its folder, Fda Qsr Audit Prep needs Python for the scripts in its folder and the command-line tools its instructions call (python3). Our summary lists: Python 3.
Does Fda Qsr Audit Prep 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 Qsr Audit Prep 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. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.
What licence does Fda Qsr Audit Prep use?
Fda Qsr Audit Prep is published under the MIT licence (declared in SKILL.md). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Fda Qsr Audit Prep use?
About 1.9k tokens (SKILL.md is roughly 7.8k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 5.2k tokens, read only when the agent opens those files.
What are the alternatives to Fda Qsr Audit Prep?
Skills that share tags, products or a category with Fda Qsr Audit Prep: Paper to Chinese Patent Drafter (Yuan1z0825/nature-skills, 46k stars), C15t (c15t/c15t, 1.9k stars), Contract Review (evolsb/claude-legal-skill, 462 stars) and Legal Clinic Client Intake (anthropics/claude-for-legal, 9.6k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Fda Qsr Audit Prep?
borghei (a GitHub user) maintains it in borghei/Claude-Skills, which has 881 GitHub stars. The repository holds 349 skills in this directory. The repository was last updated on October 7, 2026.
Source: borghei/Claude-Skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.