FreePublished on GitHub

ra-qm-skills

12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills

Run score Not tested

See how to install

Files included (74)

SKILL.md2.2 KB
.claude-plugin/plugin.json640 B
.codex/instructions.md1.3 KB
capa-officer/references/effectiveness-verification-guide.md13.3 KB
capa-officer/references/rca-methodologies.md15.4 KB
capa-officer/scripts/capa_tracker.py20.5 KB
capa-officer/scripts/root_cause_analyzer.py17.4 KB
capa-officer/SKILL.md14.5 KB
CLAUDE.md4.3 KB
fda-consultant-specialist/references/device_cybersecurity_guidance.md17.9 KB
fda-consultant-specialist/references/fda_capa_requirements.md21.9 KB
fda-consultant-specialist/references/fda_submission_guide.md11.5 KB
fda-consultant-specialist/references/hipaa_compliance_framework.md18.8 KB
fda-consultant-specialist/references/qsr_compliance_requirements.md18.4 KB
fda-consultant-specialist/scripts/fda_submission_tracker.py19.2 KB
fda-consultant-specialist/scripts/hipaa_risk_assessment.py22.6 KB
fda-consultant-specialist/scripts/qsr_compliance_checker.py24.1 KB
fda-consultant-specialist/SKILL.md10.0 KB
final-complete-skills-collection.md8.6 KB
gdpr-dsgvo-expert/references/dpia_methodology.md10.7 KB
gdpr-dsgvo-expert/references/gdpr_compliance_guide.md8.8 KB
gdpr-dsgvo-expert/references/german_bdsg_requirements.md8.7 KB
gdpr-dsgvo-expert/scripts/data_subject_rights_tracker.py18.8 KB
gdpr-dsgvo-expert/scripts/dpia_generator.py20.2 KB
gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py15.1 KB
gdpr-dsgvo-expert/SKILL.md7.7 KB
information-security-manager-iso27001/references/incident-response.md11.0 KB
information-security-manager-iso27001/references/iso27001-controls.md9.4 KB
information-security-manager-iso27001/references/risk-assessment-guide.md8.2 KB
information-security-manager-iso27001/scripts/compliance_checker.py15.8 KB
information-security-manager-iso27001/scripts/risk_assessment.py16.9 KB
information-security-manager-iso27001/SKILL.md11.4 KB
isms-audit-expert/references/cloud-security-audit.md6.1 KB
isms-audit-expert/references/iso27001-audit-methodology.md6.6 KB
isms-audit-expert/references/security-control-testing.md7.0 KB
isms-audit-expert/scripts/isms_audit_scheduler.py8.9 KB
isms-audit-expert/SKILL.md7.5 KB
mdr-745-specialist/references/clinical-evidence-requirements.md9.2 KB
mdr-745-specialist/references/mdr-classification-guide.md8.7 KB
mdr-745-specialist/references/technical-documentation-templates.md10.1 KB
mdr-745-specialist/scripts/mdr_gap_analyzer.py17.7 KB
mdr-745-specialist/SKILL.md9.7 KB
qms-audit-expert/references/iso13485-audit-guide.md10.7 KB
qms-audit-expert/references/nonconformity-classification.md6.7 KB
qms-audit-expert/scripts/audit_schedule_optimizer.py13.4 KB
qms-audit-expert/SKILL.md9.5 KB
quality-documentation-manager/references/21cfr11-compliance-guide.md13.1 KB
quality-documentation-manager/references/document-control-procedures.md11.7 KB
quality-documentation-manager/scripts/document_validator.py22.3 KB
quality-documentation-manager/scripts/document_version_control.py16.6 KB
quality-documentation-manager/SKILL.md13.7 KB
quality-manager-qmr/references/management-review-guide.md10.1 KB
quality-manager-qmr/references/quality-kpi-framework.md11.5 KB
quality-manager-qmr/scripts/management_review_tracker.py19.0 KB
quality-manager-qmr/scripts/quality_effectiveness_monitor.py18.8 KB
quality-manager-qmr/SKILL.md17.6 KB
quality-manager-qms-iso13485/references/iso13485-clause-requirements.md22.4 KB
quality-manager-qms-iso13485/references/qms-process-templates.md19.5 KB
quality-manager-qms-iso13485/scripts/qms_audit_checklist.py29.5 KB
quality-manager-qms-iso13485/SKILL.md16.0 KB
README.md32.3 KB
regulatory-affairs-head/references/eu-mdr-submission-guide.md3.2 KB
regulatory-affairs-head/references/fda-submission-guide.md3.8 KB
regulatory-affairs-head/references/global-regulatory-pathways.md9.6 KB
regulatory-affairs-head/references/iso-regulatory-requirements.md13.8 KB
regulatory-affairs-head/scripts/regulatory_pathway_analyzer.py22.5 KB
regulatory-affairs-head/scripts/regulatory_tracker.py8.0 KB
regulatory-affairs-head/SKILL.md19.7 KB
risk-management-specialist/references/iso14971-implementation-guide.md14.1 KB
risk-management-specialist/references/risk-analysis-methods.md13.0 KB
risk-management-specialist/references/risk-assessment-templates.md1.9 KB
risk-management-specialist/scripts/fmea_analyzer.py15.9 KB
risk-management-specialist/scripts/risk_matrix_calculator.py13.9 KB
risk-management-specialist/SKILL.md15.1 KB

SKILL.md (original)

Review the instructions the agent will receive before you install.

Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

Quick Start

Claude Code

/read ra-qm-team/regulatory-affairs-head/SKILL.md

Codex CLI

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

Skills Overview

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

Python Tools

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

Rules

Load only the specific skill SKILL.md you need
Always verify compliance outputs against current regulations

Reviews

No reviews yet. Tell others what you thought.

Comments

No login needed. Share how it worked for you, ask a question, or note where it did not run.

No comments yet. Be the first to write one.

More skills from this repository

acquiring-disk-image-with-dd-and-dcfldd

Free

Create forensically sound bit-for-bit disk images using dd and dcfldd while preserving evidence integrity through hash verification.

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

algorithmic-art

Free

Creating algorithmic art using p5.js with seeded randomness and interactive parameter exploration. Use this when users request creating art using code, generative art, algorithmic art, flow fields, or particle systems. Create original algorithmic art rather than copying existing artists' work to avoid copyright violations.

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

analyzing-active-directory-acl-abuse

Free

Detect dangerous ACL misconfigurations in Active Directory using ldap3 to identify GenericAll, WriteDACL, and WriteOwner abuse paths

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

analyzing-android-malware-with-apktool

Free

Perform static analysis of Android APK malware samples using apktool for decompilation, jadx for Java source recovery, and androguard for permission analysis, manifest inspection, and suspicious API call detection.

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

analyzing-api-gateway-access-logs

Free

Parses API Gateway access logs (AWS API Gateway, Kong, Nginx) to detect BOLA/IDOR attacks, rate limit bypass, credential scanning, and injection attempts. Uses pandas for statistical analysis of request patterns and anomaly detection. Use when investigating API abuse or building API-specific threat detection rules.

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

analyzing-apt-group-with-mitre-navigator

Free

Analyze advanced persistent threat (APT) group techniques using MITRE ATT&CK Navigator to create layered heatmaps of adversary TTPs for detection gap analysis and threat-informed defense.

The English summary is being prepared. Showing the original description.

micsapp/micstec-skills4Updated Mar 20, 2026

See all skills by micsapp

Report a problem with this skill

Install

Install with a command

npx skills add https://github.com/micsapp/micstec-skills --skill ra-qm-skills

Paste it into your terminal and run it (requires Node.js). You can choose which agents to install it for, such as Claude Code or Codex.

Ask your agent

Please install the following Agent Skill.
https://github.com/micsapp/micstec-skills/tree/master/claude-code/claude-skills-192/ra-qm-team

First review SKILL.md and the bundled files and confirm there is nothing suspicious (such as sending data externally or reading credentials). Then place it in ~/.claude/skills/ra-qm-skills/ for Claude Code, or ~/.agents/skills/ra-qm-skills/ for Codex.

Send this text to Claude Code or Codex as is. It checks the contents before installing.

View source on GitHub

Repository: micsapp/micstec-skills
Stars: 4
Forks: 0
Category: Testing & Security
License: MIT
Original language: English
Last updated: Mar 20, 2026

A skill is a set of instructions and scripts for an agent. cccskills does not guarantee that skills are safe. Review the contents before you install.