Medical Device Risk Management (ISO 14971:2007/2012) - Interpretation and Practical Implementation Techniques / 2 Days

Day One

1) Introduction to Medical Device Risk Management

  • Introduction
  • Regulation, Guidance & Standards (FDA & ISO)
  • Scope of ISO 14971
  • Risk Management is More than Risk Analysis

2) Risk Management Terms and Definitions (ISO 14971)

  • General Terms and Definitions
  • Conceptual Example & Exercise (Man Hole)
  • Risk
  • Risk Assessment
  • Risk Analysis
  • Hazards
  • Hazardous Situation
  • Harm
  • Risk Evaluation
  • Risk Control
  • Residual Risk

3) ISO 14971 – General Requirements

  • General Requirements for Risk Management
  • Risk Management Process
  • Management Responsibilities
  • Qualification of Personnel
  • Risk Management Plan
  • Risk Management File
  • Example

4) Risk Analysis

  • Risk Analysis
  • Risk Analysis Process
  • Intended Use and Identification of Characteristics Related Medical Device Safety
  • Hazard Analysis
  • Examples (Hazards, Hazardous Situation – ISO 14971)
  • Estimate Risks for Hazardous Situations
  • Exercise (Misuse)
  • Quiz
  • Exercise

Lunch

 5) Risk Evaluation

  • Risk Evaluation
  • Quiz
  • Exercise

6) Risk Control

  • Risk Control
  • Risk Reduction Required
  • Risk Control Option Analysis
  • Implementation of Risk Control Measures
  • Verification of Risk Control
  • Residual Risk Evaluation
  • Risk vs. Benefit Analysis
  • Evaluation of Overall Residual Risk Acceptability
  • Completeness of Risk Control
  • Quiz
  • ISO 14971 Examples
  • Exercise Implement risk controls exercise

Day Two

7) General Topics

  • Risk Management Report
  • Production and Post-Production Information
  • Progressive Risk Management throughout product development lifecycle
  • Quiz

 8) Risk Analysis Techniques

  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Mode and Effects Analysis (FMEA)
  • Exercise

Lunch

 9) Risk Management and Design Control

  • Integration of Design Controls and Risk Management
  • Risk Management and Human Factors
  • Quiz

 10) Risk Management Process Work Shop (Group Break Out)

  • Hazard Analysis
  • Estimate Risks for Each Hazard
  • Evaluate Risk
  • Implement Risk Controls
  • Evaluate Residual Risk

11) Final Overview of Risk Management Process (Review Flow Chart & Risk Assessment)

12) Question and Answer

13) Course Assessment