Software Verification and Validation for Medical Devices
( 30 Modules )

Module #1
Introduction to Medical Device Software
Overview of medical device software, its role in healthcare, and the importance of verification and validation

Module #2
Regulatory Framework for Medical Devices
Regulations and standards governing medical devices, including FDA and IEC guidelines

Module #3
Software Development Life Cycle
Understanding the software development life cycle, including requirements gathering, design, implementation, testing, and maintenance

Module #4
Verification and Validation Fundamentals
Defining verification and validation, their differences, and importance in medical device software

Module #5
Risk Management for Medical Devices
Understanding risk management principles and their application to medical device software development

Module #6
Verification Planning
Creating a verification plan, including verification strategies and test cases

Module #7
Unit Testing
Unit testing principles, techniques, and tools for medical device software

Module #8
Integration Testing
Integration testing principles, techniques, and tools for medical device software

Module #9
System Testing
System testing principles, techniques, and tools for medical device software

Module #10
Verification of Non-Functional Requirements
Verifying non-functional requirements, such as performance, security, and usability

Module #11
Validation Planning
Creating a validation plan, including validation strategies and test cases

Module #12
Clinical Validation
Clinical validation principles, techniques, and tools for medical device software

Module #13
Performance Validation
Validating performance requirements, including accuracy, precision, and reliability

Module #14
Usability and User Experience Validation
Validating usability and user experience requirements for medical device software

Module #15
Regulatory Submission and Approval
Preparing regulatory submissions and obtaining approval for medical device software

Module #16
Model-Based Design and Verification
Using model-based design and verification techniques for medical device software

Module #17
Agile Development and Verification
Applying agile development principles to medical device software development and verification

Module #18
Human Factors and Usability Engineering
Applying human factors and usability engineering principles to medical device software design and validation

Module #19
Cybersecurity for Medical Devices
Ensuring cybersecurity for medical device software

Module #20
Post-Market Surveillance and Vigilance
Monitoring and reporting adverse events and performing post-market surveillance for medical device software

Module #21
Verification and Validation Tools
Overview of verification and validation tools, including testing frameworks and automation tools

Module #22
Model-Driven Engineering Tools
Using model-driven engineering tools, such as Simulink and Stateflow, for medical device software development

Module #23
Agile Project Management Tools
Using agile project management tools, such as Jira and Trello, for medical device software development

Module #24
Cloud-Based Infrastructure for Medical Devices
Using cloud-based infrastructure for medical device software development and deployment

Module #25
Artificial Intelligence and Machine Learning in Medical Devices
Applying artificial intelligence and machine learning principles to medical device software development and validation

Module #26
Case Study:Verification and Validation of a Medical Device
Real-world example of verification and validation for a medical device

Module #27
Best Practices for Verification and Validation
Industry best practices for verification and validation of medical device software

Module #28
Lessons Learned from Medical Device Recalls
Analyzing recalls and quality issues in medical devices and applying lessons learned to verification and validation

Module #29
Collaboration and Communication in Verification and Validation
Importance of collaboration and communication among stakeholders in verification and validation

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Software Verification and Validation for Medical Devices career

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Software Verification and Validation for Medical Devices ( 30 Modules )

Software Verification and Validation for Medical Devices
( 30 Modules )