Medical Software Validation and Verification
( 30 Modules )

Module #1
Introduction to Medical Software Validation and Verification
Overview of medical software validation and verification, importance, and regulatory requirements

Module #2
Regulatory Framework for Medical Software
FDA, EU MDR, and IEC 62304 regulations for medical software

Module #3
Risk Management in Medical Software Development
Risk analysis, risk assessment, and risk mitigation in medical software development

Module #4
Software Development Life Cycle (SDLC) for Medical Devices
Overview of SDLC, including requirements gathering, design, implementation, testing, and deployment

Module #5
Design Controls for Medical Software
Design inputs, design outputs, and design verification in medical software development

Module #6
Implementation and Unit Testing of Medical Software
Implementation of medical software, unit testing, and code reviews

Module #7
Verification of Medical Software
Verification methods, including reviews, walkthroughs, and inspections

Module #8
Validation of Medical Software
Validation methods, including testing, validation protocols, and reports

Module #9
Test Case Development for Medical Software
Test case development, including black box, white box, and gray box testing

Module #10
Test Data Management for Medical Software
Test data management, including test data creation, management, and analysis

Module #11
Validation Testing of Medical Software
Validation testing, including functional, performance, and usability testing

Module #12
Validation Report and Documentation
Validation report writing, including template creation and report content

Module #13
Cybersecurity in Medical Software Validation and Verification
Cybersecurity threats, vulnerabilities, and risk management in medical software

Module #14
Artificial Intelligence and Machine Learning in Medical Software
AI and ML applications in medical software, including validation and verification challenges

Module #15
Cloud-Based Medical Software Validation and Verification
Cloud-based medical software, including validation and verification considerations

Module #16
Audits and Assessments in Medical Software Validation and Verification
Audits and assessments, including internal audits, supplier audits, and regulatory audits

Module #17
Corrective and Preventive Actions (CAPA) in Medical Software
CAPA process, including incident reporting, root cause analysis, and corrective action implementation

Module #18
Continuous Improvement in Medical Software Validation and Verification
Continuous improvement methods, including lessons learned, process improvements, and metrics analysis

Module #19
Case Study:Medical Imaging Software Validation and Verification
Real-world case study of medical imaging software validation and verification

Module #20
Case Study:Medical Device Software Validation and Verification
Real-world case study of medical device software validation and verification

Module #21
Best Practices in Medical Software Validation and Verification
Industry best practices, including lessons learned, and implementation strategies

Module #22
Tools for Medical Software Validation and Verification
Overview of tools for medical software validation and verification, including testing, validation, and verification tools

Module #23
ALM (Application Lifecycle Management) Tools for Medical Software
ALM tools, including requirements management, testing, and version control

Module #24
Test Automation in Medical Software Validation and Verification
Test automation frameworks, including Selenium, Appium, and Cucumber

Module #25
Cloud-Based Tools for Medical Software Validation and Verification
Cloud-based tools, including cloud-based testing, validation, and verification platforms

Module #26
Final Project:Medical Software Validation and Verification Case Study
Students work on a final project, applying course concepts to a real-world medical software validation and verification case study

Module #27
Final Project Presentations and Feedback
Students present their final projects, receive feedback, and discuss lessons learned

Module #28
Conclusion and Next Steps in Medical Software Validation and Verification
Course conclusion, including next steps, resources, and networking opportunities

Module #29
Medical Software Validation and Verification Resources and References
Additional resources and references for medical software validation and verification

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

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Medical Software Validation and Verification ( 30 Modules )

Medical Software Validation and Verification
( 30 Modules )