Agent skill · research science · aiskillstore
risk-management-specialist
Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.
Why this skill is useful
Provides detailed methodologies and frameworks for risk management specific to medical devices, which the AI wouldn't reliably generate on its own.
What it needs
About 5k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior Risk Management Specialist Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities. Core Risk Management Competencies 1. Risk Management Process Implementation (ISO 14971) Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle. Risk Management Process Framework: 2. Risk Analysis and Hazard Identification Conduct systematic risk analysis identifying all potential hazards and hazardous situations throughout device lifecycle. Risk Analysis Methodology: 1. Intended Use and Context Analysis Medical indication and patient population Use environment and conditions User characteristics and training Decision Point: Define scope of risk analysis 2. Hazard Identification Process For Hardware Components: Mechanical, electrical, thermal, chemical hazards For Software Components: Software failure modes per IEC 62304 For Combination Products: Drug-device interaction risks For Connected Devices: Cybersecurity and data privacy risks 3. Hazardous Situation Analysis Sequence of events leading to hazardous situations Foreseeable misuse and use error scenarios Single fault condition analysis Multiple fault condition evaluation 3. Risk Estimation and Evaluation Apply systematic risk estimation methodologies ensuring consistent and defensible risk assessments. Risk Estimation Framework: Probability Assessment: Statistical data, literature, expert judgment Severity Assessment: Clinical outcome evaluation and classification Risk Level Determination: Risk matrix application and documentation Risk Acceptability Evaluation: Criteria application and justification Risk Evaluation Decision Tree: 4. Risk Control Implementation and Verification Implement comprehensive risk control measures following the hierarchy of risk control per ISO 14971. Risk Control Hierarchy: 1. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/risk-management-specialist