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

Biomedical Device Prototyping and Testing
( 24 Modules )

Module #1
Introduction to Biomedical Device Prototyping and Testing
Overview of the biomedical device industry, importance of prototyping and testing, and course objectives
Module #2
Biomedical Device Regulations and Standards
Understanding FDA regulations, ISO standards, and CE marking for biomedical devices
Module #3
Design Controls for Biomedical Devices
Design controls, design inputs, design outputs, and design verification
Module #4
Materials Selection for Biomedical Devices
Material properties, biocompatibility, and sterilization methods
Module #5
Prototyping Methods for Biomedical Devices
3D printing, machining, casting, and other prototyping methods
Module #6
Rapid Prototyping for Biomedical Devices
Rapid prototyping techniques, such as SLA, SLS, and FDM
Module #7
Bioprinting for Biomedical Devices
Introduction to bioprinting, bioprinting techniques, and applications
Module #8
Electronics and Sensors for Biomedical Devices
Introduction to electronics, sensors, and microcontrollers for biomedical devices
Module #9
Software Development for Biomedical Devices
Introduction to software development, programming languages, and software testing
Module #10
Prototyping for Human Factors and User Experience
Designing for usability, human factors, and user experience
Module #11
Testing and Validation Methods for Biomedical Devices
Introduction to testing and validation, testing methods, and validation protocols
Module #12
Mechanical Testing for Biomedical Devices
Mechanical testing methods, such as tensile testing and fatigue testing
Module #13
Electrical and Electronic Testing for Biomedical Devices
Electrical and electronic testing methods, such as insulation testing and electromagnetic compatibility testing
Module #14
Biological and Chemical Testing for Biomedical Devices
Biological and chemical testing methods, such as cytotoxicity testing and sterility testing
Module #15
Clinical Trial Design and Conduct
Introduction to clinical trials, trial design, and trial conduct
Module #16
Data Analysis and Interpretation for Biomedical Devices
Data analysis methods, statistical analysis, and data interpretation
Module #17
Risk Management and Failure Analysis for Biomedical Devices
Risk management, failure analysis, and root cause analysis
Module #18
Design for Manufacturability and Scalability
Designing for manufacturability, scalability, and cost-effectiveness
Module #19
Supply Chain Management for Biomedical Devices
Supply chain management, procurement, and logistics
Module #20
Regulatory Submissions and Approvals
Regulatory submissions, approvals, and clearances for biomedical devices
Module #21
Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and adverse event reporting
Module #22
Biomedical Device Patenting and Intellectual Property
Patenting and intellectual property protection for biomedical devices
Module #23
Entrepreneurship and Business Development for Biomedical Devices
Entrepreneurship, business development, and fundraising for biomedical devices
Module #24
Course Wrap-Up & Conclusion
Planning next steps in Biomedical Device Prototyping and Testing career


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