Medical Device Prototyping and Testing
( 30 Modules )

Module #1
Introduction to Medical Device Prototyping and Testing
Overview of the medical device industry, importance of prototyping and testing, and course objectives

Module #2
Regulatory Framework for Medical Devices
FDA regulations, classification, and approval processes for medical devices

Module #3
Design Controls for Medical Devices
Design control principles, design inputs, and design verification

Module #4
Materials Selection for Medical Devices
Overview of biomaterials, material properties, and selection criteria

Module #5
Prototyping Methods for Medical Devices
Introduction to prototyping methods, including 3D printing, machining, and casting

Module #6
Design for Manufacturability (DFM) and Assembly
Design principles for efficient manufacturing and assembly

Module #7
Computer-Aided Design (CAD) for Medical Devices
Introduction to CAD software and design principles for medical devices

Module #8
Prototype Testing and Validation
Introduction to testing methods, including mechanical, electrical, and biocompatibility testing

Module #9
Biocompatibility Testing for Medical Devices
Overview of biocompatibility testing, including cytotoxicity, sensitization, and irritation testing

Module #10
Sterilization and Cleaning Validation
Introduction to sterilization methods, including ethylene oxide, gamma radiation, and steam sterilization

Module #11
Electrical Safety Testing for Medical Devices
Overview of electrical safety testing, including IEC 60601-1 and IEC 61010-1

Module #12
Performance Testing for Medical Devices
Introduction to performance testing, including functional, durability, and validation testing

Module #13
Packaging and Labeling for Medical Devices
Overview of packaging and labeling requirements for medical devices

Module #14
Design Verification and Validation
Introduction to design verification and validation methods, including testing and inspection

Module #15
Risk Management for Medical Devices
Overview of risk management principles, including hazard analysis and FMEA

Module #16
Clinical Evaluation and Testing
Introduction to clinical evaluation and testing methods, including clinical trials and pilot studies

Module #17
Manufacturing and Quality Control for Medical Devices
Overview of manufacturing and quality control processes, including GMP and ISO 13485

Module #18
Medical Device Commercialization and Launch
Introduction to commercialization and launch strategies for medical devices

Module #19
Post-Market Surveillance and Vigilance
Overview of post-market surveillance and vigilance requirements for medical devices

Module #20
Medical Device Regulations in Emerging Markets
Overview of medical device regulations in emerging markets, including Asia, Latin America, and Middle East

Module #21
Medical Device Innovation and Entrepreneurship
Introduction to medical device innovation and entrepreneurship, including ideation, funding, and startup strategies

Module #22
Medical Device Patenting and Intellectual Property
Overview of patenting and intellectual property protection for medical devices

Module #23
Medical Device Sterilization and Sterility Assurance
Introduction to sterilization methods and sterility assurance for medical devices

Module #24
Medical Device Microbiology and Infection Control
Overview of microbiology and infection control principles for medical devices

Module #25
Medical Device Software Development and Validation
Introduction to software development and validation principles for medical devices

Module #26
Medical Device Human Factors and Usability
Overview of human factors and usability principles for medical devices

Module #27
Medical Device Cybersecurity and Data Privacy
Introduction to cybersecurity and data privacy principles for medical devices

Module #28
Medical Device Recalls and Corrections
Overview of recall and correction principles for medical devices

Module #29
Medical Device Case Studies and Success Stories
Real-world case studies and success stories of medical device development and commercialization

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Prototyping and Testing career

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Medical Device Prototyping and Testing ( 30 Modules )

Medical Device Prototyping and Testing
( 30 Modules )