Ensure Compliance With Regulatory Excellence

Provides HealthTech and MedTech organizations with expert guidance for navigating complex regulatory and quality requirements. Medical device and healthcare software companies face strict requirements across EU MDR, FDA, ISO 13485 QMS, ISO 14971 risk management, ISO 27001 information security, and GDPR privacy regulations. This domain provides comprehensive frameworks and checklists for regulatory compliance, quality systems, and audit preparation.

Once installed, you upload regulatory skills to Claude for compliance guidance and quality frameworks. 1. Choose your focus: regulatory (FDA/MDR pathways), quality (QMS/ISO 13485), risk (ISO 14971), security (ISO 27001/GDPR), or audit (internal/external auditing). 2. Upload SKILL.md and reference guides for your jurisdiction and regulations. 3. Run Python tools for compliance checking, documentation generation, audit tracking, and reporting. 4. Use frameworks for CAPA processes, risk registers, management reviews, and regulatory submissions. Output: regulatory roadmaps, compliance checklists, audit-ready documentation, and risk management registers.

Requires understanding of regulatory frameworks: EU MDR 2017/745, FDA QSR 820, ISO 13485:2016, ISO 14971:2019, ISO 27001:2022, GDPR/DSGVO. Python tools generate compliance reports, track findings, and manage documentation. All frameworks and templates are customizable for specific device types (Class I, II, III) and regulatory contexts. No external tool dependencies; all documentation is markdown-based.