'iso-13485' 검색 결과

Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.

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• Choosing a skill for ISO 13485 audit preparation
• Routing questions about EU AI Act risk classification
• Finding the right workflow for GDPR requests

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

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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.

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ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.

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ISO 13485 medical device quality management compliance guidance

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12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

한국어 요약은 준비 중입니다. 원문 설명을 표시하고 있습니다.