Our Approach
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