12 production-ready compliance skills for HealthTech and MedTech organizations.
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AI-first code editor with Composer
Before installing skills in Cursor, ensure your development environment meets these requirements:
node --versionra-qm-skillsExecute the skills CLI command in your project's root directory to begin installation:
Fetches ra-qm-skills from alirezarezvani/claude-skills and configures it for Cursor.
The CLI shows a list of agents. Use arrow keys and space to select Cursor:
Confirm successful installation by checking the skill directory location:
Restart Cursor to activate ra-qm-skills. Access via /ra-qm-skills in your agent's command palette.
We perform automated surface-level scans (Gen AI Scanner, Socket, Snyk) during installation. These checks detect common vulnerabilities but do not guarantee complete security. Always review skill source code and verify the publisher's reputation before production use.
Skills execute code in your environment. Always review source, verify the publisher, and test in isolation before production.
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Create detailed user stories, acceptance criteria, and feature specs
Example
Generate user stories for 'password reset feature' with acceptance criteria, edge cases, and test scenarios
Reduce spec writing time by 50%, ensure comprehensive coverage
Research competitors, compare features, identify gaps
Example
Analyze 5 competitor products, create feature comparison matrix, suggest differentiation opportunities
Complete competitive research in 2 hours instead of 2 days
Evaluate features using frameworks (RICE, ICE, Kano) and create prioritized backlogs
Example
Score 20 feature ideas using RICE framework, generate prioritized roadmap with rationale
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12 production-ready compliance skills for HealthTech and MedTech organizations.
/read ra-qm-team/regulatory-affairs-head/SKILL.md
npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
| Skill | Folder | Focus |
|---|---|---|
| Regulatory Affairs Head | regulatory-affairs-head/ |
FDA/MDR strategy, submissions |
| Quality Manager (QMR) | quality-manager-qmr/ |
QMS governance, management review |
| Quality Manager (ISO 13485) | quality-manager-qms-iso13485/ |
QMS implementation, doc control |
| Risk Management Specialist | risk-management-specialist/ |
ISO 14971, FMEA, risk files |
| CAPA Officer | capa-officer/ |
Root cause analysis, corrective actions |
| Quality Documentation Manager | quality-documentation-manager/ |
Document control, 21 CFR Part 11 |
| QMS Audit Expert | qms-audit-expert/ |
ISO 13485 internal audits |
| ISMS Audit Expert | isms-audit-expert/ |
ISO 27001 security audits |
| Information Security Manager | information-security-manager-iso27001/ |
ISMS implementation |
| MDR 745 Specialist | mdr-745-specialist/ |
EU MDR classification, CE marking |
| FDA Consultant | fda-consultant-specialist/ |
510(k), PMA, QSR compliance |
| GDPR/DSGVO Expert | gdpr-dsgvo-expert/ |
Privacy compliance, DPIA |
17 scripts, all stdlib-only:
python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help
Make data-driven prioritization decisions faster
Draft PRDs, status updates, and stakeholder presentations
Example
Create executive summary of Q3 roadmap, monthly progress report, feature launch announcement
Save 3-5 hours/week on communication overhead
Prerequisites
Time Estimate
30-60 minutes to see productivity improvements
Steps
Common Pitfalls
✓ Do
✗ Don't
💡 Pro Tips
✓ Use when
Use for user story writing, competitive research, roadmap prioritization, stakeholder communication, and PRD drafting. Best for reducing repetitive documentation and research work.
✗ Avoid when
Avoid for strategic product vision (requires deep customer empathy), pricing decisions (needs market and financial expertise), or when face-to-face customer discovery is more valuable than speed.
alirezarezvani/claude-skills
JuliusBrussee/caveman
JuliusBrussee/caveman
whyashthakker/agent-skills-marketing
mattpocock/skills
parcadei/continuous-claude-v3
Keeps context tight: ra-qm-skills is the kind of skill you can hand to a new teammate without a long onboarding doc.
Registry listing for ra-qm-skills matched our evaluation — installs cleanly and behaves as described in the markdown.
ra-qm-skills is among the better-maintained entries we tried; worth keeping pinned for repeat workflows.
ra-qm-skills reduced setup friction for our internal harness; good balance of opinion and flexibility.
ra-qm-skills is among the better-maintained entries we tried; worth keeping pinned for repeat workflows.
Registry listing for ra-qm-skills matched our evaluation — installs cleanly and behaves as described in the markdown.
Solid pick for teams standardizing on skills: ra-qm-skills is focused, and the summary matches what you get after install.
Keeps context tight: ra-qm-skills is the kind of skill you can hand to a new teammate without a long onboarding doc.
Useful defaults in ra-qm-skills — fewer surprises than typical one-off scripts, and it plays nicely with `npx skills` flows.
Useful defaults in ra-qm-skills — fewer surprises than typical one-off scripts, and it plays nicely with `npx skills` flows.
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