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

Medical Device Design and Innovation
( 30 Modules )

Module #1
Introduction to Medical Device Design and Innovation
Overview of the medical device industry, importance of design and innovation, and course objectives
Module #2
Regulatory Fundamentals
Understanding FDA regulations, CE marking, and other global regulatory requirements for medical devices
Module #3
Design Controls and Risk Management
Implementing design controls, risk management, and human factors in medical device design
Module #4
Medical Device Classification and Categorization
Classifying medical devices, understanding device categorization, and implications for design and development
Module #5
Anatomy and Physiology for Medical Device Designers
Understanding human anatomy and physiology, and its application to medical device design
Module #6
Design Thinking and Ideation
Introduction to design thinking, ideation techniques, and user-centered design principles
Module #7
Materials Science for Medical Devices
Selection and application of materials for medical devices, including biomaterials and nanomaterials
Module #8
Mechanical Engineering for Medical Devices
Mechanical design principles, mechanisms, and systems for medical devices
Module #9
Electrical Engineering for Medical Devices
Electrical design principles, circuit analysis, and electronics for medical devices
Module #10
Software Engineering for Medical Devices
Software design principles, programming languages, and software verification and validation
Module #11
User Experience (UX) Design for Medical Devices
Designing user interfaces, user experience, and usability testing for medical devices
Module #12
Prototyping and Testing Medical Devices
Prototyping methods, testing and validation of medical devices, and regulatory considerations
Module #13
Medical Device Safety and Sterilization
Ensuring medical device safety, sterilization methods, and infection control
Module #14
Medical Device Packaging and Labeling
Packaging and labeling requirements for medical devices, including environmental considerations
Module #15
Manufacturing and Quality Control
Manufacturing processes, quality control, and quality assurance for medical devices
Module #16
Medical Device Commercialization and Marketing
Commercialization strategies, marketing, and sales of medical devices
Module #17
Medical Device Innovation and Entrepreneurship
Entrepreneurial principles, innovation strategies, and startup considerations for medical device innovation
Module #18
Global Medical Device Industry Trends and Outlook
Current trends, future outlook, and emerging opportunities in the global medical device industry
Module #19
Medical Device Intellectual Property and Patent Law
Intellectual property protection, patent law, and IP strategies for medical devices
Module #20
Medical Device Clinical Trials and Regulatory Submissions
Conducting clinical trials, preparing regulatory submissions, and obtaining device approvals
Module #21
Medical Device Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and complaint handling for medical devices
Module #22
Medical Device Standards and Harmonization
International standards, harmonization efforts, and their impact on medical device design and development
Module #23
Medical Device Cybersecurity and Privacy
Cybersecurity threats, risk management, and privacy considerations for medical devices
Module #24
Medical Device Supply Chain Management
Supply chain management, procurement, and logistics for medical devices
Module #25
Medical Device Sterilization and Disinfection
Sterilization and disinfection methods, validation, and control for medical devices
Module #26
Medical Device Risk Management and Failure Mode Analysis
Risk management, failure mode analysis, and fault tree analysis for medical devices
Module #27
Medical Device Human Factors and Usability
Human factors engineering, usability testing, and user-centered design principles
Module #28
Medical Device Clinical Evaluation and Performance
Clinical evaluation, performance testing, and device performance metrics
Module #29
Medical Device Regulatory Affairs and Compliance
Regulatory affairs, compliance, and quality systems for medical devices
Module #30
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Design and Innovation career


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