alirezarezvani/claude-skills

../../../engineering-team/aws-solution-architect/SKILL.md

Campaign performance analysis with engagement metrics, ROI calculations, and platform benchmarks.

Evaluate and compare technologies, frameworks, and cloud providers with data-driven analysis and actionable recommendations.

Test-driven development skill for generating tests, analyzing coverage, and guiding red-green-refactor workflows across Jest, Pytest, JUnit, and Vitest.

42 production-ready marketing skills organized into 7 specialist pods with a context foundation and orchestration layer.

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

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

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

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

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.

Expert guidance and automation for Microsoft 365 Global Administrators managing tenant setup, user lifecycle, security policies, and organizational optimization.

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

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

Production-ready financial analysis toolkit providing ratio analysis, DCF valuation, budget variance analysis, and rolling forecast construction. Designed for financial analysts with 3-6 years experience performing financial modeling, forecasting & budgeting, management reporting, business performance analysis, and...

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

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.

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