3 skills found
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 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').
Expert for Information Security Management Systems (ISMS) according to ISO 27001:2022, with deep knowledge of BaFin requirements, EU-DORA, NIS2, and German regulatory landscape. Specializes in data reuse patterns, workflow optimization, and compliance automation. Automatically activated for ISO 27001, BaFin, DORA, NIS2, compliance frameworks, and ISMS topics.
Senior ISMS Audit Expert for internal and external information security management system auditing. Provides ISO 27001 audit expertise, security audit program management, security control assessment, and compliance verification. Use for ISMS internal auditing, external audit preparation, security control testing, and ISO 27001 certification support.
