Regulatory & Quality

19 skills in this domain

Install all: claude /plugin install ra-qm-skills

• Agent Decision Receipts

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  A log says an action happened. A receipt is tamper-evident: it records who, what, and under which policy, and it is s...

• CAPA Officer

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  Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cau...

• EU AI Act Compliance Specialist

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  Article-cited operational skill for Regulation (EU) 2024/1689. Three decisions, no executive AI strategy:

• FDA Consultant Specialist

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  FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management Syste...

• GDPR/DSGVO Expert

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  Tools and guidance for EU General Data Protection Regulation (GDPR) and German Bundesdatenschutzgesetz (BDSG) complia...

• Information Security Manager - ISO 27001

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  Implement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regula...

• ISMS Audit Expert

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  Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and c...

• ISO/IEC 42001 AI Management System Specialist

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  Internal-audit-grade operating skill for ISO/IEC 42001:2023. Three decisions, no executive AI strategy:

• MDR 2017/745 Specialist

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  EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

• QMS Audit Expert

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  ISO 13485 internal audit methodology for medical device quality management systems.

• Quality Documentation Manager

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  Document control system design and management for ISO 13485-compliant quality management systems, including numbering...

• Senior Quality Manager Responsible Person (QMR)

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  Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause...

• Quality Manager - QMS ISO 13485 Specialist

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  ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device or...

• Regulatory Affairs & Quality Management Skills — Router

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  This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16^th folder under r...

• Head of Regulatory Affairs

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  Regulatory strategy development, submission management, and global market access for medical device organizations.

• Risk Management Specialist

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  ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

• SOC 2 Compliance

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  SOC 2 Type I and Type II compliance preparation for SaaS companies. Covers Trust Service Criteria mapping, control ma...