gdpr-dsgvo-expert

senior-secops

alirezarezvani

Comprehensive SecOps skill for application security, vulnerability management, compliance, and secure development practices. Includes security scanning, vulnerability assessment, compliance checking, and security automation. Use when implementing security controls, conducting security audits, responding to vulnerabilities, or ensuring compliance requirements.

senior-backend

alirezarezvani

Comprehensive backend development skill for building scalable backend systems using NodeJS, Express, Go, Python, Postgres, GraphQL, REST APIs. Includes API scaffolding, database optimization, security implementation, and performance tuning. Use when designing APIs, optimizing database queries, implementing business logic, handling authentication/authorization, or reviewing backend code.

information-security-manager-iso27001

alirezarezvani

Senior Information Security Manager specializing in ISO 27001 and ISO 27002 implementation for HealthTech and MedTech companies. Provides ISMS implementation, cybersecurity risk assessment, security controls management, and compliance oversight. Use for ISMS design, security risk assessments, control implementation, and ISO 27001 certification activities.

quality-manager-qmr

alirezarezvani

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning.

regulatory-affairs-head

alirezarezvani

Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.

mdr-745-specialist

alirezarezvani

EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation.

fda-consultant-specialist

alirezarezvani

Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.

quality-manager-qms-iso13485

alirezarezvani

ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.

isms-audit-expert

alirezarezvani

Senior ISMS Audit Expert for internal and external information security management system auditing. Provides ISO 27001 audit expertise, security audit program management, security control assessment, and compliance verification. Use for ISMS internal auditing, external audit preparation, security control testing, and ISO 27001 certification support.

Configuring MCP Servers & Plugins for Claude Code

modu-ai

Set up Model Context Protocol servers (GitHub, Filesystem, Brave Search, SQLite). Configure OAuth, manage permissions, validate MCP structure. Use when integrating external tools, APIs, or expanding Claude Code capabilities.

moai-domain-security

modu-ai

Modu-AI's Agentic Development Kit

Authoring CLAUDE.md Project Instructions

modu-ai

Design project-specific AI guidance, document workflows, define architecture patterns. Use when creating CLAUDE.md files for projects, documenting team standards, or establishing AI collaboration guidelines.