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Risk Management to Medical Device
Program/Course Introduction
Overview
Learning Objectives
Who will Benefit from This Training
Materials Used
Program Overview
Course Introduction
Course Overview
Learning Objectives
Risk Framwork
Overview
Risk Estimation - Severity
Risk Estimation - Probability
How to Score a Risk
Risk Acceptability
Toolbox
Overview
Fault Tree Analysis
Ishikawa or Fishbone Diagram
Risk Management Plan
Overview
Scope
Assignment of Responsibilities and Authorities - Part 1
Assignment of Responsibilities and Authorities - Part 2
Risk Management Activities
Requirements for Review of Risk Management Activities
Criteria of Risk Acceptability
Method to Evaluate the Overall Residual Risk
Verification Activities
Activities Related to Collection and Review of Relevant Production and PostProduction Information
Relationships to other Plans
Integration
Risk Management File
Risk File
Traceability
Family of Devices
Conclusion
Criteria of Risk Acceptability
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