risk-analysis-methods
Systematic techniques for hazard identification and risk analysis in medical device development.
Content Preview
# Risk Analysis Methods Systematic techniques for hazard identification and risk analysis in medical device development. --- ## Table of Contents - [Method Selection Guide](#method-selection-guide) - [FMEA - Failure Mode and Effects Analysis](#fmea---failure-mode-and-effects-analysis) - [FTA - Fault Tree Analysis](#fta---fault-tree-analysis) - [HAZOP - Hazard and Operability Study](#hazop---hazard-and-operability-study) - [Use Error Analysis](#use-error-analysis) - [Software Hazard Analysis]
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/risk-analysis-methods.md \
https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/risk-management-specialist/references/risk-analysis-methods.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/alirezarezvani/claude-skillsThen reference at ra-qm-team/risk-management-specialist/references/risk-analysis-methods.md
Related Skills
cs-quality-regulatory
Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.
agentsqualityregulatoryagent
by alirezarezvani · alirezarezvani-claude-skills
risk-assessment-guide
Risk Assessment Methodology Guide
ra-qm-teamriskassessmentguide
by alirezarezvani · alirezarezvani-claude-skills
risk-assessment-templates
risk-management-specialist reference
ra-qm-teamriskassessmenttemplates
by alirezarezvani · alirezarezvani-claude-skills
SKILL
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
ra-qm-teamskillagentpython
by alirezarezvani · alirezarezvani-claude-skills