HIPAA Safe Harbor Coverage Audit
maziyarpanahi/openmed
Checks OpenMed de-identified clinical text against the 18 HIPAA Safe Harbor identifier categories and reports gaps and residual re-identification risk.
/cs:iso13485-audit-prep <scope — ISO 13485 QMS audit 6-question forcing interrogation.
Install Iso13485 Audit Prep
$ npx skills add alirezarezvani/claude-skills --skill iso13485-audit-prep -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install alirezarezvani/claude-skills iso13485-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/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .claude/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .claude/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-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 alirezarezvani/claude-skills --skill iso13485-audit-prep -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install alirezarezvani/claude-skills iso13485-audit-prep --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .agents/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .agents/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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 alirezarezvani/claude-skills --skill iso13485-audit-prep -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install alirezarezvani/claude-skills iso13485-audit-prep --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .cursor/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .cursor/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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/alirezarezvani/claude-skills.git --path compliance-os/skills/iso13485-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 alirezarezvani/claude-skills --skill iso13485-audit-prep -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install alirezarezvani/claude-skills iso13485-audit-prep --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .gemini/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .gemini/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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 alirezarezvani/claude-skills iso13485-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 alirezarezvani/claude-skills --skill iso13485-audit-prep -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .github/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .github/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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 alirezarezvani/claude-skills --skill iso13485-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 alirezarezvani/claude-skills iso13485-audit-prep --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/compliance-os/skills/iso13485-audit-prep .opencode/skills/iso13485-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 "iso13485-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/iso13485-audit-prep into .opencode/skills/iso13485-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "iso13485-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
iso13485-audit-prep- GitHub stars
- 28k
- Token cost
- ~1.7k tokens
- SKILL.md length
- 464 words
- Files
- 1
- Skills in repo
- 342
- Repo updated
- First seen
- Licence
- MIT
At a glance
/cs:iso13485-audit-prep <scope — ISO 13485 QMS audit 6-question forcing interrogation.
- Works in 6 steps: Pull three random DHFs. Are design… → Show me the last 5 CAPAs with… → When was process validation (IQ/OQ/PQ)… → …
- Tasks that involve Audit readiness
- SKILL.md covers When to Run, The Six QMS Questions, Workflow and Output Format, plus 2 more sections
- Calls python
What it does
Iso13485 Audit Prep is an agent skill from alirezarezvani/claude-skills. /cs:iso13485-audit-prep <scope — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit.
Its SKILL.md is about 1.7k 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 and Product launch strategy. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.
When your agent uses it
- Tasks that involve Audit readiness
- Tasks that involve Product launch strategy
Example prompts
- “/iso13485-audit-prep”
Requirements
- Python 3
Workflow steps
6 steps, taken from the step headings in SKILL.md.
- Pull three random DHFs. Are design verification + validation evidence complete?
- Show me the last 5 CAPAs with effectiveness verification evidence.
- When was process validation (IQ/OQ/PQ) last revalidated?
- Show me the risk management file for the highest-risk product.
- Show me post-market surveillance evidence — last 6 months.
- Where's the management review evidence covering all Clause 5.6 inputs?
What it can do on your machine
Read from SKILL.md and the folder at commit 19392f7. 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
Shell commands in SKILL.md call:
python
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
Iso13485 Audit Prep loads about 1.7k tokens when it runs. Until then it costs about 66 tokens; SKILL.md has 464 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 alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 464 words, ~1,665 tokens.
Download SKILL.mdSave it as
.claude/skills/iso13485-audit-prep/SKILL.md (or your agent's skills folder).- name
- iso13485-audit-prep
- description
- /cs:iso13485-audit-prep <scope> — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit.
/cs:iso13485-audit-prep — ISO 13485 QMS Forcing Questions
Command: /cs:iso13485-audit-prep <scope>
The ISO 13485 QMS auditor pressure-tests any medical-device QMS work. Six traceability-obsessed questions before any internal audit, MDR / FDA QSR review, or product launch.
When to Run
- Before annual Clause 8.2.4 internal audit
- Before MDR / FDA QSR alignment review (substantially harmonized post Feb 2026)
- Before new-device commercial launch (DHF closure audit)
- After significant CAPA closure event (effectiveness verification audit)
- Post-recall event (root cause + corrective action audit)
- Quarterly during regulatory submission preparation
The Six QMS Questions
1. Pull three random DHFs. Are design verification + validation evidence complete?
Most-cited finding area.
- DHF must include: design plan + inputs + outputs + verification + validation + transfer + changes
- Sample stratified by product class (I, IIa, IIb, III per MDR)
- Reference
iso13485_audit_playbook.mdfor the per-DHF checklist - Verify traceability matrix from user needs through clinical evidence
2. Show me the last 5 CAPAs with effectiveness verification evidence.
Second-most-cited finding area.
- Containment / correction / corrective action distinction documented
- Root cause analysis depth: 5 Why minimum
- Effectiveness verification = measurable evidence, not "we updated the procedure"
- Closure approved by appropriate authority
- Repeat CAPAs across products = systemic issue trigger
3. When was process validation (IQ/OQ/PQ) last revalidated?
Clause 7.5.6 — often stale.
- Initial validation at process introduction
- Revalidation triggers: process change, equipment change, material change, periodic schedule
- Trend monitoring (SPC) where statistical techniques apply per Clause 8.4
- Cross-check with cs-fda-qsr-auditor for 21 CFR 820.75 alignment
4. Show me the risk management file for the highest-risk product.
Clause 7.1 + ISO 14971:2019.
- Risk management plan exists per product
- Hazard identification covers reasonable foreseeable misuse
- Risk control hierarchy applied: inherent safety > protective measures > information for safety
- Residual risk evaluated + accepted with rationale
- Post-production information feeds back into RMF
- For AI-enabled medical devices: layer ISO 42001 A.5 impact assessment on top
Show full SKILL.md (174 more words)Show less
5. Show me post-market surveillance evidence — last 6 months.
Clause 8.2.1 — high-stakes for MDR + FDA.
- Customer complaint log + investigation closure
- Vigilance reports (serious incident / FSCA) submitted per applicable regulation
- Trend analysis evidence + management review input
- Post-market clinical follow-up (PMCF) for MDR high-risk devices
- MDR reports per 21 CFR 803 for US-marketed devices (cross-check with cs-fda-qsr-auditor)
6. Where's the management review evidence covering all Clause 5.6 inputs?
Annual minimum; semi-annual for mature programs.
- Required inputs per Clause 5.6.2: audit results, customer feedback, process performance, product conformity, status of preventive + corrective actions, follow-up from prior reviews, changes that could affect QMS, recommendations for improvement, regulatory requirements
- Outputs per Clause 5.6.3: improvement decisions, product requirement changes, resource needs
- Integrated review across frameworks (per
multi_framework_audit_playbook.md) preferred
Workflow
# 1. Audit programme optimization
python ra-qm-team/skills/qms-audit-expert/scripts/audit_schedule_optimizer.py audit_scope.json
# 2. Mock audit for readiness check
python ../../skills/compliance-os/scripts/audit_simulator.py iso13485_scope.json
# 3. CAPA system review
# Route to ra-qm-team/skills/capa-officer/ tools
# 4. Risk management file review
# Route to ra-qm-team/skills/risk-management-specialist/ toolsOutput Format
# ISO 13485 Audit Prep: <scope>
**Date:** YYYY-MM-DD
## The Decision Being Made
[programme-plan | DHF-closure | CAPA-health | post-market-trend | pre-cert | MDR-FDA-alignment]
## Design Control Status (sampled DHFs)
- DHFs sampled: <list product IDs>
- Verification evidence: pass/fail per DHF
- Validation evidence: pass/fail per DHF
- Clinical evidence (per MDR Annex XIV / FDA 510(k)): pass/fail
- Traceability matrix complete: yes/no per DHF
## CAPA Health
- CAPAs sampled: N
- Root cause analysis depth: adequate/inadequate per CAPA
- Effectiveness verification: complete/incomplete per CAPA
- Aging CAPAs > 90 days: N
- Repeat issues across products: <list>
## Process Validation Status
- Validations on schedule: %
- Stale validations (> 12 months since revalidation): <list>
- Statistical techniques applied per Clause 8.4: yes/no
## Risk Management File Status
- Sampled product RMFs: <list>
- Post-production updates in last 12 months: <count per product>
- Residual risk acceptance signed: yes/no
## Post-Market Surveillance
- Complaint trending: stable/rising
- MDR / vigilance reports filed timely: %
- PMCF on schedule (where required): yes/no
## Management Review Status
- Last review date: YYYY-MM-DD
- Required Clause 5.6.2 inputs present: yes/no
- Open action items past due: N
## Cross-Framework Impact
- EU MDR alignment: clean / gaps in <list>
- FDA QSR alignment (post-Feb 2026): substantially harmonized; FDA-specific overlays per cs-fda-qsr-auditor
- ISO 42001 AIMS overlay (if AI-enabled device): pass/fail per Annex A
## Verdict
🟢 READY | 🟡 CLOSE-DHF-GAPS-FIRST | 🔴 NOT-READY
## Top 3 Actions
[3 concrete next steps with owner + corrective-action timeline]Routing
/cs:compliance-readiness— for multi-framework view/cs:fda-qsr-audit-prep— for FDA-specific overlay/cs:aims-audit— for AI-enabled medical device ISO 42001 layer/cs:gdpr-audit-prep— for personal-data overlap (clinical data, customer data)/cs:cpo-review— for executive product strategy decisions/cs:decide— to log the verdict
Related
- Agent:
cs-cqm-iso13485 - Skill:
qms-audit-expert - Playbook: iso13485_audit_playbook.md
- Adjacent:
../fda-qsr-audit-prep/,../aims-audit/,../compliance-readiness/
Version: 1.0.0
© alirezarezvani, 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 compliance-os/skills/iso13485-audit-prep of alirezarezvani/claude-skills.
Open the folder on GitHubat commit 19392f7
Compare with similar skills
Iso13485 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 |
|---|---|---|---|---|---|---|
| Iso13485 Audit Prep this skillalirezarezvani/claude-skills | 28k | — | ~1.7k | Automated safety check: Pass | MIT | |
| 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 | 943 | 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 |
Similar skills
ISO Standards Readiness Evidence
K-Dense-AI/scientific-agent-skills
Organizes scope, controlled documents, risk files and traceability into draft evidence for human review against ISO 13485, 14971, 17025 and 15189.
Iso42001
Sushegaad/Claude-Skills-Governance-Risk-and-Compliance
Expert ISO 42001 AI Management System (AIMS) compliance advisor.
- Official
Fleet Triage
google-labs-code/jules-sdk
Cognitive triage of fleet audit findings. An agent skill from google-labs-code/jules-sdk.
PCI DSS Compliance
wshobson/agents
Reference for building payment systems that meet PCI DSS: the 12 requirements, merchant levels, data that must never be stored, tokenization and encryption.
Trust Center Builder
GRCEngClub/claude-grc-engineering
Builds and deploys a serverless trust center that publishes a company's compliance posture, with gated access to audit reports and an admin dashboard.
More from alirezarezvani/claude-skills
All 342 skills in this repoAgile Product Owner
alirezarezvani/claude-skills
Writes INVEST-checked user stories with acceptance criteria, splits epics, plans sprints from velocity and ranks the backlog with a weighted score.
Product Strategist
alirezarezvani/claude-skills
OKR cascade toolkit for product leaders: generates aligned company-to-team OKRs from five strategy types and scores how well they line up.
App Store Optimization
alirezarezvani/claude-skills
App Store Optimization (ASO) toolkit for researching keywords, analyzing competitor rankings, generating metadata suggestions, and improving app visibility on Apple App Store and Google Play Store.
AWS Solution Architect
alirezarezvani/claude-skills
Design AWS architectures for startups using serverless patterns and IaC templates.
Campaign Analytics
alirezarezvani/claude-skills
Calculates attribution, funnel and ROI figures for marketing campaigns with three Python scripts that need only the standard library.
Code to PRD
alirezarezvani/claude-skills
Reverse-engineers a frontend, backend or fullstack codebase into a product requirements document with per-page docs, an enum dictionary and an API inventory.
Related
Categories
Questions about Iso13485 Audit Prep
What does Iso13485 Audit Prep do?
/cs:iso13485-audit-prep <scope — ISO 13485 QMS audit 6-question forcing interrogation. Iso13485 Audit Prep is an agent skill from alirezarezvani/claude-skills. /cs:iso13485-audit-prep <scope — ISO 13485 QMS audit 6-question forcing interrogation.
When should I use Iso13485 Audit Prep?
Iso13485 Audit Prep fits situations like: tasks that involve Audit readiness; tasks that involve Product launch strategy.
How do I install Iso13485 Audit Prep in Claude Code?
Run `npx skills add alirezarezvani/claude-skills --skill iso13485-audit-prep -a claude-code`. Or copy the skill folder (compliance-os/skills/iso13485-audit-prep in alirezarezvani/claude-skills) into .claude/skills/iso13485-audit-prep in your project. Claude Code loads it when a task matches its description.
How do I install Iso13485 Audit Prep in Codex?
Run `npx skills add alirezarezvani/claude-skills --skill iso13485-audit-prep -a codex`. Or copy the skill folder (compliance-os/skills/iso13485-audit-prep in alirezarezvani/claude-skills) into .agents/skills/iso13485-audit-prep in your project. Codex loads it when a task matches its description.
Can I use Iso13485 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 alirezarezvani/claude-skills --skill iso13485-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/iso13485-audit-prep, .gemini/skills/iso13485-audit-prep, .github/skills/iso13485-audit-prep and .opencode/skills/iso13485-audit-prep in your project.
What does Iso13485 Audit Prep need to run?
Going by SKILL.md and its folder, Iso13485 Audit Prep needs the command-line tools its instructions call (python). Our summary lists: Python 3.
Does Iso13485 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 Iso13485 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. Review the folder before installing.
What licence does Iso13485 Audit Prep use?
Iso13485 Audit Prep 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 Iso13485 Audit Prep use?
About 1.7k tokens (SKILL.md is roughly 6.7k 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 Iso13485 Audit Prep?
Skills that share tags, products or a category with Iso13485 Audit Prep: 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, 943 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 Iso13485 Audit Prep?
alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,891 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.
Source: alirezarezvani/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.