Risk Management Specialist
Skill Verifiziert AktivMedical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
To guide users through the rigorous process of medical device risk management according to ISO 14971, ensuring compliance and product safety.
Funktionen
- Implements ISO 14971 risk management framework
- Provides workflows for risk planning, analysis, evaluation, and control
- Includes post-production risk monitoring guidance
- Offers risk assessment templates and decision frameworks
- Supports hazard identification, FMEA, FTA, HAZOP, and Use Error Analysis
Anwendungsfälle
- Use when performing risk analysis for a new medical device.
- Use when updating risk management documentation for existing devices.
- Use when evaluating the acceptability of identified risks.
- Use when implementing and verifying risk control measures.
Nicht-Ziele
- Performing the risk management activities autonomously without user input
- Providing regulatory submission documents directly
- Replacing a certified quality management system
Installation
Zuerst Marketplace hinzufügen
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQualitätspunktzahl
VerifiziertVertrauenssignale
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