Risk Management in Medical Device Development
( 25 Modules )

Module #1
Introduction to Risk Management
Overview of risk management principles and regulatory requirements in medical device development

Module #2
Risk Management Standards and Regulations
In-depth review of ISO 14971, FDA, and EU MDR regulations

Module #3
Risk Management Process Overview
Phased approach to risk management, from design to post-market surveillance

Module #4
Hazard Identification and Risk Analysis
Tools and techniques for identifying hazards and analyzing risks

Module #5
Risk Assessment and Evaluation
Methods for assessing and evaluating risks, including risk matrices and FMEA

Module #6
Risk Control and Mitigation Strategies
Designing and implementing risk control measures

Module #7
Verification and Validation of Risk Controls
Methods for verifying and validating risk control measures

Module #8
Risk-Benefit Analysis
Balancing risks and benefits in medical device development

Module #9
Risk Management in Design Controls
Integrating risk management into design controls and design verification

Module #10
Human Factors and Risk Management
Assessing and mitigating user-related risks

Module #11
Manufacturing and Sterilization Risks
Risk management in manufacturing and sterilization processes

Module #12
Packaging and Labeling Risks
Risk management in packaging and labeling processes

Module #13
Supply Chain Risk Management
Identifying and mitigating risks in the supply chain

Module #14
Clinical Trial Risk Management
Risk management in clinical trials and study design

Module #15
Post-Market Surveillance and Vigilance
Monitoring and responding to risks in the post-market phase

Module #16
Risk Management in Medical Device Software
Unique considerations for software-based medical devices

Module #17
Cybersecurity Risks in Medical Devices
Identifying and mitigating cybersecurity risks in medical devices

Module #18
Regulatory Submissions and Compliance
Regulatory requirements for risk management in medical device submissions

Module #19
Risk Management Audits and Assessments
Conducting internal audits and assessments to ensure compliance

Module #20
Risk Management Training and Competency
Developing a risk management culture and training programs

Module #21
Risk Management Tools and Templates
Using tools and templates to facilitate risk management processes

Module #22
Case Studies in Risk Management
Real-world examples of risk management in medical device development

Module #23
Best Practices in Risk Management
Industry-recognized best practices and lessons learned

Module #24
Future Trends in Risk Management
Emerging trends and technologies in risk management for medical devices

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

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Risk Management in Medical Device Development ( 25 Modules )

Risk Management in Medical Device Development
( 25 Modules )