Basic Principles of Risk Management for Medical Device Design

Figure 1. Risk Management Flow Chart

Basic Principles of Risk Management for Medical Device Design

Figure 2. Safety Risk Zone

Basic Principles of Risk Management for Medical Device Design

Basic Principles of Risk Management for Medical Device Design

Basic Principles of Risk Management for Medical Device Design

Basic Principles of Risk Management for Medical Device Design

Figure 3. Risk Assessment Matrix

Basic Principles of Risk Management for Medical Device Design

Figure 4. A Partial Fault Tree Analysis for a Pacemaker

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