15 skills
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gdpr-data-handling

Safe 69

Implement GDPR compliant data handling

by wshobson

GDPR requirements are complex and easy to miss during development. This skill provides clear patterns for consent management, data subject rights, and privacy by design to help you build compliant systems.

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employment-contract-templates

Safe 69

Generate Employment Contracts and HR Documents

by wshobson

Create legally sound employment documents quickly and consistently. This skill provides professionally drafted templates for contracts, offer letters, and HR policies that comply with employment law best practices.

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🛡️

risk-management-specialist

Safe 79

Manage Medical Device Risk with ISO 14971 Expertise

by davila7

Medical device companies must implement comprehensive risk management throughout product lifecycle to meet regulatory requirements. This skill provides expert guidance on ISO 14971 implementation covering risk analysis, evaluation, control, and post-production monitoring.

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regulatory-affairs-head

Safe 79

Guide regulatory affairs for HealthTech

by davila7

HealthTech and MedTech companies need expert regulatory guidance to navigate complex FDA and EU MDR requirements. This skill provides strategic regulatory affairs leadership including submission planning, compliance frameworks, and cross-functional team coordination for successful market access.

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qms-audit-expert

Safe 80

Lead QMS Audits for ISO 13485 Compliance

by davila7

Quality management system audits require deep regulatory knowledge and systematic methodology. This skill provides expert guidance for ISO 13485 audits, nonconformity identification, and corrective action verification.

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gdpr-dsgvo-expert

Safe 80

Analyze GDPR compliance and data protection

by davila7

Organizations face complex EU GDPR and German DSGVO requirements that require specialized expertise. This skill provides expert guidance on compliance frameworks, privacy impact assessments, data subject rights management, and regulatory verification.

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fda-consultant-specialist

Safe 81

Navigate FDA regulations for medical devices

by davila7

Medical device companies face complex FDA compliance requirements that delay market entry. This skill provides expert guidance on FDA pathways, QSR requirements, HIPAA compliance, and regulatory submission strategies.

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risk-management-specialist

Safe 80

Manage medical device risk with ISO 14971 frameworks

by alirezarezvani

Medical device companies face complex risk management requirements across product lifecycles. This skill provides expert guidance for implementing ISO 14971 risk management processes including hazard identification, risk estimation, control measures, and post-market surveillance.

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⚖️

regulatory-affairs-head

Safe 80

Lead Regulatory Strategy for Medical Devices

by alirezarezvani

Medical device companies face complex global regulatory requirements that delay market access and increase compliance costs. This skill provides expert regulatory affairs guidance for FDA submissions, EU MDR compliance, ISO certifications, and cross-functional team coordination.

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quality-manager-qms-iso13485

Safe 81

Implement ISO 13485 Quality Management Systems

by alirezarezvani

Medical device companies struggle to build and maintain compliant ISO 13485 quality management systems. This skill provides expert guidance on QMS implementation, documentation control, internal audits, and regulatory compliance for ISO 13485 certification.

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🔍

qms-audit-expert

Safe 81

Audit Quality Management Systems with ISO 13485 Expertise

by alirezarezvani

This skill provides expert guidance for planning, executing, and managing ISO 13485 audits. It includes risk-based audit planning tools, nonconformity tracking, and CAPA integration workflows for medical device organizations.

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⚕️

fda-consultant-specialist

Safe 81

Navigate FDA medical device compliance

by alirezarezvani

Medical device companies face complex FDA regulations and HIPAA requirements. This skill provides expert guidance on 510(k) submissions, QSR compliance, and healthcare data protection for efficient market access.

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capa-officer

Safe 81

Manage CAPA Processes and Root Cause Analysis

by alirezarezvani

This skill provides expert-level guidance for managing Corrective and Preventive Actions within Quality Management Systems. It offers systematic root cause analysis techniques, corrective action planning frameworks, and effectiveness verification procedures for regulatory compliance.

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📦

water-rights-fishing

Safe 70

Process water rights and fishing regulations efficiently

by ACSKamloops

Administrative workflows for water licenses and fishing restrictions require specialized knowledge of regional Indigenous territory regulations. This skill helps clerks efficiently navigate complex water rights and fishing regulations for Pukaist and Nlaka'pamux territories.

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fiduciary-duty-negligence

Safe 70

Analyze Crown fiduciary negligence documents

by ACSKamloops

Legal researchers need to systematically review and index historical records of Crown fiduciary breaches. This skill provides a clerk workflow to extract verbatim evidence from documents while maintaining legal-grade standards and neutrality.

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