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

Design for Manufacturing and Testing Medical Devices
( 25 Modules )

Module #1
Introduction to Design for Manufacturing and Testing (DFM/DFT)
Overview of the importance of DFM/DFT in medical device development
Module #2
Regulatory Framework for Medical Devices
Understanding FDA, CE, and ISO regulations for medical device design and testing
Module #3
Design Controls and Risk Management
Applying design controls and risk management principles to medical device development
Module #4
Material Selection for Medical Devices
Material properties, selection, and testing for medical device applications
Module #5
Design for Manufacturability (DFM) Principles
Best practices for designing medical devices for manufacturability
Module #6
Design for Testability (DFT) Principles
Design considerations for testing and verification of medical devices
Module #7
Mechanical Design for Medical Devices
Design considerations for mechanical components and assemblies
Module #8
Electronics Design for Medical Devices
Design considerations for electronic components and circuits
Module #9
Software Design for Medical Devices
Design considerations for software and firmware in medical devices
Module #10
Human Factors Engineering for Medical Devices
Designing medical devices for user safety and ease of use
Module #11
Designing for Sterilization and Cleaning
Design considerations for sterilization and cleaning of medical devices
Module #12
Packaging and Labeling for Medical Devices
Designing packaging and labeling for medical devices
Module #13
Designing for Reliability and Maintainability
Design considerations for reliability and maintainability of medical devices
Module #14
Testing and Verification of Medical Devices
Types of testing and verification methods for medical devices
Module #15
Electrical Safety Testing for Medical Devices
Electrical safety testing requirements and methods for medical devices
Module #16
Mechanical Testing for Medical Devices
Mechanical testing requirements and methods for medical devices
Module #17
Biocompatibility Testing for Medical Devices
Biocompatibility testing requirements and methods for medical devices
Module #18
Software Verification and Validation for Medical Devices
Software verification and validation methods for medical devices
Module #19
Design for Manufacturability (DFM) Tools and Techniques
Computer-aided design (CAD) and other tools for DFM
Module #20
Design for Testability (DFT) Tools and Techniques
Tools and techniques for designing testable medical devices
Module #21
Prototyping and Pilot Production for Medical Devices
Prototyping and pilot production strategies for medical devices
Module #22
Scaling Up to Full-Scale Production for Medical Devices
Challenges and strategies for scaling up to full-scale production
Module #23
Supply Chain Management for Medical Devices
Supply chain management strategies for medical devices
Module #24
Case Studies in Design for Manufacturing and Testing
Real-world examples of successful DFM/DFT in medical device development
Module #25
Course Wrap-Up & Conclusion
Planning next steps in Design for Manufacturing and Testing Medical Devices career


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