무료GitHub에 공개

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).

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills

실행 점수 미검증

설치 방법 보기

포함된 파일(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(원문)

설치하기 전에 에이전트에게 전달되는 지시 내용을 확인할 수 있습니다.

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

리뷰

아직 리뷰가 없습니다. 사용해 본 소감을 남겨 주세요.

로그인 없이 쓸 수 있습니다. 사용 후기, 질문, 작동하지 않은 환경 등을 편하게 남겨 주세요.

아직 댓글이 없습니다. 첫 댓글을 남겨 보세요.

같은 저장소의 스킬

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

무료

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

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

algorithmic-art

무료

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.

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

analyzing-active-directory-acl-abuse

무료

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

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

analyzing-android-malware-with-apktool

무료

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.

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

analyzing-api-gateway-access-logs

무료

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.

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

analyzing-apt-group-with-mitre-navigator

무료

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.

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

micsapp/micstec-skills42026년 3월 20일 업데이트

micsapp의 스킬 모두 보기

이 스킬의 문제 신고

설치

명령으로 설치

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

터미널에 붙여 넣고 실행합니다(Node.js 필요). Claude Code, Codex 등 설치할 에이전트를 고를 수 있습니다.

에이전트에게 부탁하기

다음 Agent Skill을 설치해 주세요.
https://github.com/micsapp/micstec-skills/tree/master/claude-code/claude-skills-192/ra-qm-team

먼저 SKILL.md와 첨부 파일의 내용을 확인해 수상한 처리(외부 전송, 인증 정보 읽기 등)가 없는지 확인한 뒤 Claude Code는 ~/.claude/skills/ra-qm-skills/, Codex는 ~/.agents/skills/ra-qm-skills/ 에 배치해 주세요.

이 문장을 그대로 Claude Code나 Codex에 보내면 내용을 확인한 뒤 설치해 줍니다.

GitHub에서 소스 보기

저장소: micsapp/micstec-skills
스타: 4
포크: 0
카테고리: 테스트·보안
라이선스: MIT
원문 언어: 영어
최종 업데이트: 2026년 3월 20일

스킬은 에이전트를 위한 지시와 스크립트의 묶음입니다. cccskills는 내용의 안전성을 보증하지 않습니다. 설치하기 전에 내용을 확인하세요.