risk-management-specialist

Risk Management Specialist

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

Use boundary: The bundled matrix and RPN thresholds are illustrative defaults, not values mandated by ISO 14971. A qualified risk owner must define and approve device-specific acceptability criteria, verify control effectiveness, and approve regulated records. The skill supports analysis and drafting; it does not certify compliance or replace clinical, engineering, or regulatory judgment.

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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

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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