Skills and MCP tagged “ra-qm-team”

ra-qm-skills Alireza Rezvani skill Routes regulatory and quality management queries to 15 specialised skills in the ra-qm-team bundle. Useful when a compliance task does not immediately match a single standard. Claude Code 1,653installs gdpr-dsgvo-expert Alireza Rezvani skill Scans code for GDPR and German BDSG privacy risks, builds DPIA reports, and tracks data subject rights deadlines. Claude Code 980installs risk-management-specialist Alireza Rezvani skill Implements ISO 14971:2019 risk management for medical devices across product lifecycles. It guides hazard analysis, 5x5 matrices, and risk control. Claude Code 862installs information-security-manager-iso27001 Alireza Rezvani skill Assists with ISO 27001:2022 ISMS implementation, security risk assessments, and compliance audits for HealthTech and MedTech teams. Claude Code 855installs quality-documentation-manager Alireza Rezvani skill This skill manages document control workflows for medical device QMS under ISO 13485 and 21 CFR Part 11. It helps set up numbering conventions, approval flows, and change control. Claude Code 803installs capa-officer Alireza Rezvani skill Runs CAPA investigations for a medical device QMS: root cause analysis, corrective action planning, effectiveness verification. Useful when you are working a nonconformance or an audit finding. Claude Code 795installs isms-audit-expert Alireza Rezvani skill Assists with ISO 27001 audits, control assessments, and certification readiness in Claude Code. Ideal for planning surveillance cycles and logging nonconformities. Claude Code 791installs regulatory-affairs-head Alireza Rezvani skill A Claude skill for MedTech regulatory work: prepares FDA 510(k), De Novo and PMA packages, plus CE technical documentation under EU MDR 2017/745. Claude Code 790installs quality-manager-qms-iso13485 Alireza Rezvani skill Guides ISO 13485:2016 quality management system work for medical device organizations. Use it to plan QMS implementation, prepare internal audits, and manage document control. Claude Code 784installs fda-consultant-specialist Alireza Rezvani skill This skill guides FDA pathways for medical devices, QMSR requirements, HIPAA assessments, and device cybersecurity. Use it when planning or reviewing regulatory work. Claude Code 775installs quality-manager-qmr Alireza Rezvani skill This skill supports QMR work under ISO 13485, from management reviews to quality KPI monitoring. Use it to organize evidence and document decisions. Claude Code 747installs qms-audit-expert Alireza Rezvani skill Guides ISO 13485 internal audits for medical device quality management systems. Useful when planning audit schedules, evaluating nonconformities, and preparing for external inspections. Claude Code 747installs mdr-745-specialist Alireza Rezvani skill This skill supports EU MDR 2017/745 device classification, technical documentation, clinical evaluation, and post-market surveillance planning. Claude Code 737installs soc2-compliance Alireza Rezvani skill Guides SaaS teams through SOC 2 Type I and Type II preparation. Helps map Trust Service Criteria, build control matrices, and organize audit evidence. Claude Code 658installs eu-ai-act-specialist Alireza Rezvani skill Classifies AI systems under Regulation (EU) 2024/1689, outlines conformity routes, and maps role obligations. Essential for teams auditing models against EU AI Act rules. Claude Code 394installs iso42001-specialist Alireza Rezvani skill Reviews AI management system gaps, maps risks to Annex A controls, and drafts an internal audit plan. Use it when preparing for ISO 42001 certification. Claude Code 385installs agent-decision-receipts Alireza Rezvani skill Mints tamper-evident, post-quantum-signed receipts for agent actions like deploys or payments. Lets you verify autonomous decisions offline from the certificate alone. Claude Code 44installs