Risk Management Systems
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1. Introduction

Overview of Risk Management
What is Risk Management
Benefits of Risk Management
Risk Management elements overview
Terminology
Terminology.pdf
Documentation overview
Traceability
Traceability.pdf
2. General Requirements

Top management responsibilities
Top Management Responsibilities.pdf
Risk Management Plan
Risk Management Plan.pdf
Risk Management File
Risk Management File.pdf
3. Risk Analysis

Introduction to Risk Analysis
Introduction to Risk Analysis.pdf
Characteristics related to safety
Identification of characteristics related to safety.pdf
Hazardous situations & faults
Hazardous situations.pdf
Hazard identification principles
Hazard identification principles.pdf
Hazard identification example
Overview of Risk Analysis techniques
Overview Risk Analysis techniques.pdf
Failure Mode Effect Analysis (FMEA)
FMEA.pdf
Fault Tree Analysis (FTA)
Fault Tree Analysis.pdf
Event Tree Analysis (ETA)
Event Tree Analysis.pdf
Hazard & Operability Study (HAZOP)
HAZOP.pdf
Combinations of events
Combinations of events.pdf
Risk estimation principles
Risk estimation principles.pdf
Probability estimation
Estimation of severity
4. Risk Evaluation

Risk Evaluation
Risk Evaluation.pdf
Policy for establishing risk acceptability criteria
Policy for establishing risk acceptability criteria.pdf
Risk acceptability criteria
Risk acceptability criteria.pdf
5. Risk Control

Introduction to Risk Control
Introduction to Risk Control.pdf
General thoughts on Risk Control
General thoughts on Risk Control.pdf
Overall policy for Risk Control
Overall policy for Risk Control.pdf
Risk Control option analysis
Risk Control option analysis.pdf
Implementation & verification of Risk Control
Implementation verification of Risk Control measures.pdf
Risk Control of manufacturing processes
Risk control for manufacturing processes.pdf
Residual Risk Evaluation & Benefit-Risk Analysis
Residual risk evaluation benefit risk analysis.pdf
Risk arising from Risk Control measures
Risks arising from Risk Control measures.pdf
Completeness of Risk Control
Completeness of Risk Control.pdf
6. Evaluation of overall residual risk

Evaluation of overall residual risk
Evaluation of overall residual risk.pdf
Inputs & considerations in overall residual risk evaluation
Challenges in overall residual risk evaluation
Possible approaches in overall residual risk evaluation
7. Risk Management Review

Risk Management Review
Risk Management Review.pdf
8. Production & post-production activities

Information in Production & Post-production activities
Information collection in Production & Post-production
Information review in Production & Post-production
Information actions in Production & Post-production

3. Risk Analysis

This section provides a detailed exploration of the correct approach to Risk Analysis - a core component of all medical device risk management systems.

25 Lessons