ra-qm-skills

Plugin ra-qm-skills from marketplace claude-code-skills in Ck1sap/borghei-Claude-Skills. Commands read from the repo's manifest — 1 month ago.

Skills (21)

• capa-officer

  CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CA

• ccpa-cpra-privacy-expert

  CCPA and CPRA privacy compliance automation. Audits organizations for California privacy law compliance, maps personal information flows, validates consumer rights readiness, and checks technical safeguards. Use for CCPA compliance assessments, CPRA readiness checks, privacy policy review, consumer

• dora-compliance-expert

  DORA (EU 2022/2554) digital operational resilience compliance automation for financial entities. Assesses readiness against all 5 DORA pillars, classifies ICT incidents, validates third-party risk management, and generates resilience testing plans. Use for DORA compliance assessments, ICT risk manag

• eu-ai-act-specialist

  EU AI Act (Regulation EU 2024/1689) compliance specialist. Use when classifying AI systems by risk tier, assessing provider or deployer obligations, evaluating GPAI model compliance, running conformity assessments, performing bias detection and fairness testing, building AI governance programs, or p

• fda-consultant-specialist

  FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPA

• gdpr-dsgvo-expert

  GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management. version: 1.0.0 author

• information-security-manager-iso27001

  ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare se

• infrastructure-compliance-auditor

  Cross-cutting infrastructure security audit skill that checks cloud infrastructure, DNS, TLS, endpoints, access control, network security, containers, CI/CD pipelines, secrets management, logging, and physical security against ALL major compliance frameworks. Use for infrastructure audit, cloud secu

• isms-audit-expert

  Information Security Management System auditing for ISO 27001 compliance, security control assessment, and certification support. Use when planning ISMS audit programs, executing internal or external ISO 27001 audits, testing ISO 27002 Annex A controls, managing audit findings and corrective actions

• iso42001-ai-management

  ISO 42001 AI Management System compliance automation. Assesses organizational readiness for AIMS certification, evaluates AI system impacts, validates governance structures, and checks Annex A controls. Use for ISO 42001 readiness assessments, AI governance planning, AI impact assessments, responsib

• mdr-745-specialist

  EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration. version: 1.0.0 author: borg

• nis2-directive-specialist

  NIS2 Directive (EU 2022/2555) compliance automation. Analyzes organizational scope, assesses compliance against all 10 minimum security measures, validates incident reporting readiness, and generates gap analysis reports. Use for NIS2 compliance assessments, critical infrastructure cybersecurity pla

• nist-csf-specialist

  NIST Cybersecurity Framework 2.0 implementation, assessment, and compliance management. Use for NIST cybersecurity framework, CSF 2.0, NIST compliance, cybersecurity risk management, NIST controls, NIST assessment, cybersecurity maturity, NIST CSF profile, cybersecurity governance, CSF gap analysis,

• pci-dss-specialist

  PCI DSS v4.0 payment card industry data security standard compliance, assessment, and implementation. Use for PCI DSS, payment card security, cardholder data, PCI compliance, payment security, PCI assessment, SAQ, ROC, QSA, credit card security, payment processing security, PCI scoping, tokenization

• qms-audit-expert

  ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management. version: 1.0.0 author:

• quality-documentation-manager

  Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulator

• quality-manager-qmr

  Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Use when conducting management reviews, setting quality objectives, tracking quality KPIs, assessing quality culture, overseeing regulatory compliance across jurisdictions, or preparing for Notified Body and FDA in

• quality-manager-qms-iso13485

  ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. version: 1.0.0 author: borghei category: compliance domain: quality-management updated: 2026

• regulatory-affairs-head

  Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Use when developing regulatory strategy, preparing FDA 510(k)/PMA/De Novo submissions, planning EU MDR CE marking, coordinating global market access, or monitoring regulatory intelligence. Provides pathway analysis, submission m

• risk-management-specialist

  Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. version: 1.0.0 author: borghei category: compliance domain: risk-management updated: 2026-03-31 tags: [iso-1

• soc2-compliance-expert

  SOC 2 Type I and Type II compliance management. Use when conducting SOC 2 readiness assessments, performing gap analysis against Trust Services Criteria, collecting audit evidence, validating infrastructure security controls, preparing for CPA firm audits, managing the observation period, or buildin

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