Prototyping and Testing in Medical Device Design
( 25 Modules )

Module #1
Introduction to Medical Device Design
Overview of the medical device design process, importance of prototyping and testing, and course objectives

Module #2
Design Controls and Regulatory Considerations
Understanding design controls, FDA regulations, and CE marking for medical devices

Module #3
User-Centered Design Principles
Applying user-centered design principles to medical device design, including user research and feedback

Module #4
Prototyping Methods for Medical Devices
Overview of prototyping methods, including rapid prototyping, 3D printing, and iteration

Module #5
Material Selection for Medical Devices
Selecting materials for medical devices, including biocompatibility, sterilization, and durability

Module #6
Mechanical Prototyping and Testing
Mechanical prototyping and testing methods, including stress testing and fatigue analysis

Module #7
Electrical and Electronic Prototyping and Testing
Electrical and electronic prototyping and testing methods, including circuit design and safety testing

Module #8
Software Prototyping and Testing for Medical Devices
Software prototyping and testing methods, including user interface design and verification

Module #9
Prototype Fabrication Techniques
Fabrication techniques for medical device prototypes, including machining, molding, and casting

Module #10
Prototype Testing and Validation
Testing and validation methods for medical device prototypes, including functional testing and performance evaluation

Module #11
Human Factors and Usability Testing
Conducting human factors and usability testing for medical devices, including user feedback and iterations

Module #12
Biocompatibility and Sterilization Testing
Biocompatibility and sterilization testing methods for medical devices, including ISO 10993 standards

Module #13
Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI) Testing
EMC and EMI testing methods for medical devices, including IEC 60601-1-2 standards

Module #14
Performance and Functional Testing
Performance and functional testing methods for medical devices, including testing protocols and reports

Module #15
Clinical Trials and Evaluation
Conducting clinical trials and evaluation for medical devices, including study design and protocol development

Module #16
Risk Management and Failure Mode Analysis
Risk management and failure mode analysis for medical devices, including FMEA and FTA methods

Module #17
Design Freeze and Design Verification
Design freeze and design verification processes for medical devices, including design reviews and testing

Module #18
Design Transfer and Manufacturing Readiness
Design transfer and manufacturing readiness processes for medical devices, including documentation and process validation

Module #19
Post-Market Surveillance and Vigilance
Post-market surveillance and vigilance for medical devices, including complaint handling and adverse event reporting

Module #20
Regulatory Submissions and Approvals
Regulatory submissions and approvals for medical devices, including 510(k), PMA, and CE marking

Module #21
Case Studies in Medical Device Prototyping and Testing
Real-world examples and case studies of medical device prototyping and testing, including successes and challenges

Module #22
Best Practices for Prototyping and Testing
Best practices for prototyping and testing medical devices, including lessons learned and industry trends

Module #23
Prototyping and Testing for Specific Medical Device Types
Prototyping and testing considerations for specific medical device types, including implantable devices and IVDs

Module #24
The Future of Medical Device Design and Prototyping
Emerging trends and technologies in medical device design and prototyping, including AI, robotics, and personalized medicine

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

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Prototyping and Testing in Medical Device Design ( 25 Modules )

Prototyping and Testing in Medical Device Design
( 25 Modules )