Design and Prototyping of Medical Devices
( 25 Modules )

Module #1
Introduction to Medical Device Design
Overview of medical device industry, design principles, and regulatory considerations

Module #2
Understanding User Needs
Identifying user needs, market research, and user-centered design principles

Module #3
Medical Device Classification and Regulations
Overview of FDA classification, FDA regulations, and CE marking

Module #4
Design Controls and Risk Management
Understanding design controls, risk management, and ISO 14971

Module #5
Material Selection for Medical Devices
Material properties, biocompatibility, and sterilization considerations

Module #6
Design for Manufacturability
Design considerations for manufacturing, prototyping, and production

Module #7
Mechanical Design Principles
Mechanical design principles, kinematics, and dynamics

Module #8
Electrical and Electronic Design Principles
Electrical and electronic design principles, circuit analysis, and device integration

Module #9
Software Design Principles for Medical Devices
Software design principles, programming languages, and regulatory considerations

Module #10
Human Factors and User Experience Design
Human factors, user experience design, and usability testing

Module #11
Designing for Sterilization and Cleaning
Design considerations for sterilization, cleaning, and disinfection

Module #12
Designing for Biocompatibility and Toxicology
Biocompatibility testing, toxicology, and material selection considerations

Module #13
Designing for Ergonomics and Accessibility
Ergonomic design principles, accessibility considerations, and usability testing

Module #14
Prototyping and Testing Medical Devices
Prototyping methods, testing strategies, and regulatory requirements

Module #15
Design Verification and Validation
Design verification, design validation, and regulatory requirements

Module #16
Medical Device Packaging and Labeling
Packaging considerations, labeling regulations, and UDI requirements

Module #17
Clinical Trials and Regulatory Submissions
Clinical trial design, regulatory submissions, and FDA review process

Module #18
Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and complaint handling

Module #19
Medical Device Innovation and Intellectual Property
Medical device innovation, intellectual property protection, and patent strategies

Module #20
Collaboration and Communication in Medical Device Design
Effective communication, collaboration, and project management in medical device design

Module #21
Designing for Emerging Technologies
Designing for emerging technologies, such as AI, machine learning, and robotics

Module #22
Medical Device Design for Low-Resource Settings
Designing medical devices for low-resource settings, global health considerations

Module #23
Medical Device Design for Pediatric and Geriatric Populations
Designing medical devices for pediatric and geriatric populations, special considerations

Module #24
Designing for Home Healthcare and Telemedicine
Designing medical devices for home healthcare, telemedicine, and remote patient monitoring

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Design and Prototyping of Medical Devices career

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Design and Prototyping of Medical Devices ( 25 Modules )

Design and Prototyping of Medical Devices
( 25 Modules )