12 Compliance Agent Skills
Skills for quality management and regulatory workflows.
Agent Skills for Claude Code covering ISO 13485, ISMS audits, CAPA, SOX testing, and certification readiness workflows.
Read the guide: The best compliance Agent Skills →
New to Agent Skills? Learn how to install one in under a minute →
Compliance work is evidence-heavy and procedurally precise — and most of it follows the same structure every time. Audit checklists, control frameworks, CAPA documentation, certification readiness reviews. These skills structure the recurring compliance processes so teams can prepare faster and audit better.
The skills here cover ISO 13485, ISMS audits, SOX controls testing, CAPA management, GDPR documentation, and certification readiness for regulated industries. They're built for MedTech, healthtech, and enterprise compliance teams.
Note: these are workflow and documentation tools. Compliance determinations and legal interpretations always require qualified review.
CAPA Officer
by @alirezarezvani
Manage Corrective and Preventive Actions — root cause analysis, CAPA documentation, effectiveness verification, and closing the quality loop per ISO standards.
FDA Consultant & Specialist
by @alirezarezvani
Navigate FDA regulatory pathways — 510(k), PMA, De Novo, and QSR 21 CFR Part 820 compliance for medical device manufacturers and digital health companies.
GDPR/DSGVO Expert
by @alirezarezvani
Navigate EU GDPR and German DSGVO compliance — data processing agreements, DPIAs, privacy policies, consent management, and data subject rights workflows.
Information Security Manager (ISO 27001)
by @alirezarezvani
Implement and manage an ISMS per ISO 27001/27002 — risk assessments, security controls, incident management, and certification readiness.
ISMS Audit Expert
by @alirezarezvani
Conduct ISO 27001 internal audits — audit planning, evidence collection, nonconformance identification, and management review preparation.
EU MDR 2017/745 Specialist
by @alirezarezvani
EU Medical Device Regulation compliance — device classification, UDI registration, EUDAMED submission, and technical file documentation under MDR 2017/745.
QMS Audit Expert
by @alirezarezvani
Conduct ISO 13485 internal quality management system audits — audit planning, process evaluation, nonconformance reports, and certification support.
Quality Documentation Manager
by @alirezarezvani
Manage regulatory documentation and document control systems — SOPs, work instructions, technical files, and version-controlled document management per ISO standards.
Quality Manager (QMR)
by @alirezarezvani
Quality Management Representative accountability — QMS governance, management review facilitation, compliance dashboards, and overall quality system ownership.
QMS ISO 13485 Specialist
by @alirezarezvani
Implement and maintain ISO 13485 quality management systems for medical devices — gap analysis, process design, procedure writing, and certification readiness.
Head of Regulatory Affairs
by @alirezarezvani
Lead regulatory strategy for medical devices — FDA submissions, EU MDR market access, regulatory pathway selection, and global market entry planning.
Risk Management Specialist (ISO 14971)
by @alirezarezvani
Implement ISO 14971 risk management for medical devices — FMEA, fault tree analysis, benefit-risk assessments, and risk management file maintenance.