Medical Device Software Development
( 24 Modules )

Module #1
Introduction to Medical Device Software Development
Overview of the medical device industry, software development lifecycle, and regulatory requirements

Module #2
Medical Device Regulations and Standards
In-depth review of FDA regulations, IEC 62304, and other relevant standards for medical device software development

Module #3
Software Development Life Cycle (SDLC) for Medical Devices
Applying SDLC principles to medical device software development, including requirements gathering, design, implementation, testing, and deployment

Module #4
Risk Management for Medical Device Software
Identifying and mitigating risks associated with medical device software, including hazard analysis and risk assessment

Module #5
Software Requirements Specification (SRS) for Medical Devices
Creating a comprehensive SRS for medical device software, including functional and performance requirements

Module #6
Designing Medical Device Software Architectures
Design principles and patterns for medical device software architectures, including safety and security considerations

Module #7
Implementing Medical Device Software
Programming languages, development tools, and testing frameworks for medical device software implementation

Module #8
Verification and Validation of Medical Device Software
Verifying and validating medical device software, including unit testing, integration testing, and system testing

Module #9
Software Testing for Medical Devices
Testing strategies and methods for medical device software, including black box, white box, and gray box testing

Module #10
Human-Centered Design for Medical Device Software
Designing medical device software for user experience, including user research, user personas, and usability testing

Module #11
Cybersecurity for Medical Device Software
Securing medical device software against cyber threats, including threat modeling, vulnerability analysis, and penetration testing

Module #12
Agile Development for Medical Device Software
Applying agile development methodologies to medical device software development, including Scrum and Kanban

Module #13
version Control and Configuration Management for Medical Device Software
Using version control systems and configuration management tools for medical device software development

Module #14
Medical Device Software Documentation and Record-Keeping
Creating and maintaining documentation and records for medical device software development, including design documents and testing reports

Module #15
FDA Submissions and Regulatory Approval
Preparing FDA submissions and obtaining regulatory approval for medical device software, including 510(k) and PMA

Module #16
Post-Market Surveillance and Vigilance
Monitoring and reporting adverse events, and conducting post-market surveillance for medical device software

Module #17
Software Maintenance and Updates for Medical Devices
Planning and executing software maintenance and updates for medical devices, including change control and testing

Module #18
Medical Device Software Development Teams and Roles
Organizing and managing medical device software development teams, including roles and responsibilities

Module #19
Medical Device Software Development Tools and Technologies
Overview of software development tools and technologies for medical device software development, including IDEs, compilers, and libraries

Module #20
Cloud-Based Medical Device Software Development
Developing medical device software for cloud-based deployment, including AWS and Azure

Module #21
Artificial Intelligence and Machine Learning for Medical Devices
Applying AI and ML to medical device software development, including data analysis and algorithm development

Module #22
Medical Device Software Development for Mobile and Wearable Devices
Developing medical device software for mobile and wearable devices, including iOS and Android

Module #23
Medical Device Software Development for Cyber-Physical Systems
Developing medical device software for cyber-physical systems, including embedded systems and IoT devices

Module #24
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Software Development career

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Medical Device Software Development ( 24 Modules )

Medical Device Software Development
( 24 Modules )