ra-qm-skills

Plugin ra-qm-skills from marketplace claude-code-skills in borghei/Claude-Skills. Commands read from the repo's manifest — 4 days ago.

Skills (27)

• ai-act-readiness

  EU AI Act readiness assessment and sprint playbook. Use when preparing for the high-risk AI system deadlines (Dec 2027 / Aug 2028), when a notified-body conformity assessment is scheduled, or when GPAI (general-purpose AI) obligations apply. version: 1.0.0 author: borghei category: compliance domain

• aims-audit

  ISO 42001 AI Management System (AIMS) audit-prep playbook. Use when an ISO 42001 certification audit is scheduled (Stage 1 or Stage 2), when a surveillance or internal AIMS audit is due, or when preparing an AI Impact Assessment (AIIA). version: 1.0.0 author: borghei category: compliance domain: ra-

• compliance-readiness

  Cross-framework compliance readiness orchestrator. Use when preparing for multi-framework certification (SOC 2 + ISO 27001 + NIST CSF), building a shared-evidence strategy, sequencing certifications, or mapping a control across frameworks. version: 1.0.0 author: borghei category: compliance domain:

• fda-qsr-audit-prep

  FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed. version: 1.0.0 author: borghei category: compliance domain: ra-qm-team update

• gdpr-audit-prep

  GDPR audit-prep playbook: sprint to prepare for a supervisory authority inquiry, DPA audit, or internal review. Use when an audit is scheduled, when readiness gaps surface, or when ROPA (Records of Processing Activities) needs completion. version: 1.0.0 author: borghei category: compliance domain: r

• soc2-audit-prep

  SOC 2 audit-prep playbook: the 4/8/12-week sprint to audit-ready for a Type I or Type II observation. Use when the audit is scheduled, when readiness assessment surfaced gaps and you need a sprint plan, or when evidence is missing or stale. version: 1.0.0 author: borghei category: compliance domain:

• capa-officer

  CAPA system management for medical device QMS, covering root cause analysis, corrective action planning, and effectiveness verification. Use for CAPA investigations, 5-Why and fishbone analysis, and corrective action tracking. version: 1.0.0 author: borghei category: compliance domain: corrective-ac

• ccpa-cpra-privacy-expert

  CCPA and CPRA California privacy compliance. Use for CCPA/CPRA readiness assessments, personal information data mapping, consumer rights handling, privacy policy review, opt-out mechanisms, and California privacy audits. version: 1.0.0 author: borghei category: compliance domain: privacy-compliance

• dora-compliance-expert

  DORA (EU 2022/2554) digital operational resilience compliance for financial entities, covering all 5 pillars. Use for DORA readiness assessments, ICT risk management, incident classification, and third-party ICT oversight. version: 1.1.0 author: borghei category: compliance domain: financial-resilie

• eu-ai-act-specialist

  EU AI Act (Regulation EU 2024/1689) compliance specialist. Use for AI system risk classification, provider/deployer obligations, GPAI model compliance, conformity assessments, bias and fairness testing, and AI governance programs. version: 1.0.0 author: borghei category: compliance domain: ai-govern

• fda-consultant-specialist

  FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy. version: 1.0.0 author: borghei category: compliance domain

• gdpr-dsgvo-expert

  GDPR and German DSGVO compliance. Use for GDPR compliance assessments, privacy audits, scanning codebases for privacy risks, DPIA generation, data protection planning, and data subject rights management. version: 1.0.0 author: borghei category: compliance domain: privacy-compliance updated: 2026-03-

• information-security-manager-iso27001

  ISO 27001:2022 ISMS implementation and cybersecurity governance for HealthTech and MedTech. Use for ISMS design, risk assessment per Clause 6.1.2, Annex A controls, ISO 27001 certification, security audits, and incident response. version: 1.1.0 author: borghei category: compliance domain: informatio

• infrastructure-compliance-auditor

  Cross-framework infrastructure security audit across cloud, network, and CI/CD. Use for infrastructure and cloud security audits, security posture assessment, and validating technical controls for SOC 2, ISO 27001, and NIST CSF. version: 1.1.0 author: borghei category: compliance domain: infrastruct

• isms-audit-expert

  ISMS auditing for ISO 27001 compliance, control assessment, and certification support. Use for ISMS audit programs, internal/external ISO 27001 audits, ISO 27002 Annex A control testing, and Stage 1/Stage 2 certification audits. version: 1.0.0 author: borghei category: compliance domain: security-au

• iso42001-ai-management

  ISO 42001 AI Management System (AIMS) compliance. Use for ISO 42001 readiness assessments, AI governance planning, AI impact assessments, Annex A control validation, responsible AI implementation, and AIMS certification preparation. version: 1.0.0 author: borghei category: compliance domain: ai-gove

• mdr-745-specialist

  EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Use for Annex VIII classification, GSPR, clinical evaluation, EUDAMED, and UDI. version: 1.0.0 author: borghei category: compliance domain: medical-devic

• nis2-directive-specialist

  NIS2 Directive (EU 2022/2555) compliance for critical infrastructure entities, covering the 10 minimum security measures. Use for NIS2 compliance assessments, entity scope analysis, supply chain security, and incident reporting readiness. version: 1.0.0 author: borghei category: compliance domain: c

• nist-csf-specialist

  NIST Cybersecurity Framework 2.0 implementation, assessment, and compliance management. Use for CSF 2.0 gap analysis, cybersecurity risk management, maturity assessment, CSF profiles, and cross-framework compliance mapping. version: 1.1.0 author: borghei category: compliance domain: cybersecurity-fr

• pci-dss-specialist

  PCI DSS v4.0 payment card data security compliance, assessment, and implementation. Use for PCI DSS scoping, cardholder data environment (CDE) security, SAQ and ROC preparation, QSA engagement, tokenization, and merchant compliance. version: 1.1.0 author: borghei category: compliance domain: payment

• qms-audit-expert

  ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity classification, CAPA verification, external audit preparation, or audit program management. version: 1.0.0 author: borghei category: compliance domain: quality-audit updated: 2026-03-31 tag

• quality-documentation-manager

  Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance. version: 1.0.0 author: borghei category: compliance domain: document-con

• quality-manager-qmr

  Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality objectives and KPIs, quality culture, and Notified Body / FDA inspection prep per ISO 13485 Clause 5.5.2. version: 1.0.0 author: borghei category: compliance domain: quality-management upd

• 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: 1.1.0 author: borghei category: compliance domain: quality-management updated: 2026

• regulatory-affairs-head

  Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence. version: 1.0.0 author: borghei category: compliance domain: regulatory-strategy updated: 2026-03-31 tag

• 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: 1.1.0 author: borghei category: compliance domain: risk-management updated: 2026-06-15 tags: [iso-1

• soc2-compliance-expert

  SOC 2 Type I and Type II compliance management against the Trust Services Criteria. Use for SOC 2 readiness assessments, TSC gap analysis, audit evidence collection, infrastructure control validation, and CPA firm audit preparation. version: 1.0.0 author: borghei category: compliance domain: securit

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