Agent skill · research science · alirezarezvani
risk-management-specialist
Use for ISO 14971 medical device risk management: hazard analysis, FMEA, fault trees, risk controls, benefit-risk or residual risk. Runs fmea_analyzer.py and risk_matrix_calculator.py.
Why this skill is useful
Provides detailed workflows and templates for implementing ISO 14971 risk management in medical devices, which the AI wouldn't reliably generate on its own.
What it needs
About 9k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
Risk Management Specialist ISO 14971:2019 risk management implementation throughout the medical device lifecycle. --- Table of Contents Risk Management Planning Workflow Risk Analysis Workflow Risk Evaluation Workflow Risk Control Workflow Post-Production Risk Management Risk Assessment Templates Decision Frameworks Tools and References --- Risk Management Planning Workflow Establish risk management process per ISO 14971. Workflow: Create Risk Management Plan 1. Define scope of risk management activities: Medical device identification Lifecycle stages covered Applicable standards and regulations 2. Establish risk acceptability criteria: Define probability categories (P1-P5) Define severity categories (S1-S5) Create risk matrix with acceptance thresholds 3. Assign responsibilities: Risk management lead Subject matter experts Approval authorities 4. Define verification activities: Methods for control verification Acceptance criteria 5. Plan production and post-production activities: Information sources Review triggers Update procedures 6. Obtain plan approval 7. Establish risk management file 8. Validation: Plan approved; acceptability criteria defined; responsibilities assigned; file established Risk Management Plan Content Section Content Evidence --------- --------- ---------- Scope Device and lifecycle coverage Scope statement Criteria Risk acceptability matrix Risk matrix document Responsibilities Roles and authorities RACI chart Verification Methods and acceptance Verification plan Production/Post-Production Monitoring activities Surveillance plan Risk Acceptability Matrix (5x5) Probability \ Severity Negligible Minor Serious Critical Catastrophic ------------------------ ------------ ------- --------- ---------- -------------- Frequent (P5) Medium High High Unacceptable Unacceptable Probable (P4) Medium Medium High High Unacceptable Occasional (P3) Low Medium Medium High High Remote (P2) Low Low Medium Medium High Improbable (P1) Low Low Low Medium Medium Risk …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/risk-management-specialist--6ff81b