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WIZAPE
Apprentice Mode
10 Modules / ~100 pages
Wizard Mode
~25 Modules / ~400 pages

Software Development for Medical Devices
( 30 Modules )

Module #1
Introduction to Medical Device Software Development
Overview of the medical device industry, software development lifecycle, and regulatory requirements
Module #2
Software Development Fundamentals
Basics of software development, including data types, variables, control structures, and functions
Module #3
Medical Device Software Categories
Classification of medical device software, including Class I, II, and III devices
Module #4
Regulatory Requirements for Medical Device Software
FDA, CE, and ISO regulations for medical device software development
Module #5
Software Development Methodologies
Agile, Waterfall, and V-Model development methodologies for medical device software
Module #6
Requirements Gathering and Analysis
Elucidating user needs, defining software requirements, and creating use cases
Module #7
Software Design Principles
Design principles for medical device software, including safety, security, and usability
Module #8
Programming Languages for Medical Devices
Introduction to programming languages commonly used in medical device software development
Module #9
Database Design for Medical Devices
Designing databases for medical device software, including data modeling and normalization
Module #10
Software Development Tools and Environments
Overview of integrated development environments (IDEs), version control systems, and debugging tools
Module #11
Software Testing Fundamentals
Introduction to software testing, including types of testing and testing levels
Module #12
Test Planning and Test Case Development
Creating test plans and test cases for medical device software
Module #13
Test Automation for Medical Devices
Introduction to test automation, including tools and frameworks
Module #14
Software Validation and Verification
Validating and verifying medical device software, including testing and inspection
Module #15
Risk Management for Medical Device Software
Identifying and mitigating risks associated with medical device software development
Module #16
Software Deployment Strategies
Deploying medical device software, including installation, configuration, and maintenance
Module #17
Software Maintenance and Updates
Maintaining and updating medical device software, including bug fixing and change management
Module #18
Cybersecurity for Medical Device Software
Securing medical device software, including threat modeling and vulnerability assessment
Module #19
Post-Market Surveillance
Monitoring and reporting medical device software performance, including adverse event reporting
Module #20
Software Documentation and Records
Creating and maintaining documentation for medical device software, including design controls and regulatory compliance
Module #21
Machine Learning and AI in Medical Devices
Introduction to machine learning and AI in medical device software development
Module #22
Cloud-Based Medical Device Software
Developing medical device software for cloud-based platforms
Module #23
Mobile App Development for Medical Devices
Developing mobile apps for medical devices, including iOS and Android
Module #24
Wearable Device Software Development
Developing software for wearable medical devices
Module #25
Future Trends in Medical Device Software Development
Emerging trends and technologies in medical device software development
Module #26
Project Development:Case Study 1
Developing a medical device software project, including requirements gathering and design
Module #27
Project Development:Case Study 2
Developing a medical device software project, including implementation and testing
Module #28
Project Development:Case Study 3
Developing a medical device software project, including deployment and maintenance
Module #29
Case Study:Medical Device Software Development Challenges
Real-world examples of medical device software development challenges and solutions
Module #30
Course Wrap-Up & Conclusion
Planning next steps in Software Development for Medical Devices career


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