Risk Management in Medical Device Manufacturing
( 25 Modules )

Module #1
Introduction to Risk Management in Medical Device Manufacturing
Overview of risk management principles and their application in medical device manufacturing

Module #2
Regulatory Requirements for Risk Management
Review of global regulatory requirements for risk management in medical device manufacturing, including FDA and ISO standards

Module #3
Risk Management Terminology and Concepts
Definition and explanation of key risk management terms and concepts, such as risk, hazard, harm, and mitigation

Module #4
Risk Management Process Overview
High-level overview of the risk management process, including risk analysis, evaluation, and control

Module #5
Risk Analysis:Identifying Hazards and Risk Factors
Methods and techniques for identifying hazards and risk factors in medical device manufacturing, including FMEA and HazOp

Module #6
Risk Evaluation:Assessing Risk Severity and Probability
Methods and techniques for evaluating risk severity and probability, including risk matrices and scoring systems

Module #7
Risk Control:Implementing Risk Mitigation Strategies
Methods and techniques for implementing risk mitigation strategies, including design controls, process controls, and labeling

Module #8
Risk Review and Verification
Methods and techniques for reviewing and verifying risk management processes and outcomes

Module #9
Device-Specific Risk Management:Implants and Class III Devices
Risk management considerations for high-risk medical devices, including implants and Class III devices

Module #10
Device-Specific Risk Management:Software and Cybersecurity
Risk management considerations for medical device software and cybersecurity

Module #11
Supply Chain Risk Management
Risk management strategies for managing supply chain risks in medical device manufacturing

Module #12
Human Factors and Risk Management
The role of human factors in risk management, including user error and usability considerations

Module #13
Risk Management in Design Controls
The role of risk management in design controls, including design inputs, outputs, and verification

Module #14
Risk Management in Manufacturing and Production
The role of risk management in manufacturing and production, including process controls and preventive maintenance

Module #15
Risk Management in Sterilization and Packaging
Risk management considerations for sterilization and packaging processes in medical device manufacturing

Module #16
Risk Management in Distribution and Logistics
Risk management considerations for distribution and logistics in medical device manufacturing

Module #17
Post-Market Surveillance and Risk Management
The role of post-market surveillance in risk management, including complaint handling and corrective action

Module #18
Risk Management Audits and Compliance
Conducting risk management audits and ensuring compliance with regulatory requirements

Module #19
Risk Management Tools and Techniques
Overview of risk management tools and techniques, including risk assessment templates and failure modes and effects analysis (FMEA)

Module #20
Risk Management Metrics and Performance Monitoring
Developing and tracking risk management metrics and performance monitoring

Module #21
Risk Management Communication and Training
Effective communication and training strategies for risk management in medical device manufacturing

Module #22
Risk Management in Quality Management Systems
The role of risk management in quality management systems, including ISO 13485 and FDA QSR

Module #23
Risk Management in Humanitarian Use Devices (HUDs)
Risk management considerations for humanitarian use devices (HUDs)

Module #24
Risk Management in Emergency Use Authorizations (EUAs)
Risk management considerations for emergency use authorizations (EUAs)

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Risk Management in Medical Device Manufacturing career

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Risk Management in Medical Device Manufacturing ( 25 Modules )

Risk Management in Medical Device Manufacturing
( 25 Modules )