Mint a tamper-evident, post-quantum-signed receipt for a consequential agent action (deploy, delete, pay, grant-access, model decision) so it can be verified la
所属插件包：ra-qm-skills
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when ru
所属插件包：ra-qm-skills
EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — p
所属插件包：ra-qm-skills
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by ref
所属插件包：ra-qm-skills
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests with Art. 12(3
所属插件包：ra-qm-skills
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use when designing an ISMS, running security risk assessments,
所属插件包：ra-qm-skills
Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use wh
所属插件包：ra-qm-skills
ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses
所属插件包：ra-qm-skills
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex
所属插件包：ra-qm-skills
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when plann
所属插件包：ra-qm-skills
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use whe
所属插件包：ra-qm-skills
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulato
所属插件包：ra-qm-skills
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditi
所属插件包：ra-qm-skills
Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 ris
所属插件包：ra-qm-skills
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways
所属插件包：ra-qm-skills
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-p
所属插件包：ra-qm-skills
Use when the user asks to prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess
所属插件包：ra-qm-skills
