Design of Medical Devices
( 25 Modules )

Module #1
Introduction to Medical Device Design
Overview of medical device industry, importance of design, and course objectives

Module #2
Regulatory Framework for Medical Devices
FDA regulations, EUs MDR, and other global regulatory requirements

Module #3
Design Controls and Risk Management
Design control principles, risk management strategies, and ISO 14971

Module #4
User-Centered Design and Human Factors
Principles of user-centered design, human factors, and usability testing

Module #5
Materials Selection for Medical Devices
Overview of biomaterials, material selection criteria, and sterilization methods

Module #6
Mechanical Design of Medical Devices
Mechanical design principles, mechanisms, and manufacturing processes

Module #7
Electronics and Software Design for Medical Devices
Electronics design principles, software development, and integration

Module #8
Sensors and Actuators in Medical Devices
Types of sensors, actuation principles, and applications in medical devices

Module #9
Medical Device Packaging and Labeling
Packaging design principles, labeling requirements, and sterilization validation

Module #10
Sterilization and Cleaning of Medical Devices
Sterilization methods, cleaning and disinfection protocols, and validation

Module #11
Biocompatibility and Toxicology Testing
Biocompatibility testing, toxicology testing, and biocompatibility standards

Module #12
Clinical Trials and Medical Device Validation
Clinical trial design, validation methods, and regulatory requirements

Module #13
Medical Device Reliability and Failure Analysis
Reliability principles, failure modes and effects analysis, and fault tree analysis

Module #14
Medical Device Safety and Hazard Analysis
Hazard analysis, risk assessment, and safety standards for medical devices

Module #15
Medical Device Maintenance and Servicing
Maintenance and servicing strategies, documentation, and regulatory requirements

Module #16
Medical Device Quality Management Systems
Quality management principles, ISO 13485, and quality system implementation

Module #17
Medical Device Standards and Guidelines
Overview of relevant standards and guidelines, such as ISO, IEC, and ASTM

Module #18
Medical Device Design for Emerging Markets
Design considerations for medical devices in emerging markets, including cultural and regulatory factors

Module #19
Medical Device Design for Sustainability
Designing medical devices for environmental sustainability, including eco-design principles

Module #20
Medical Device Design for Accessibility
Designing medical devices for accessibility, including universal design principles

Module #21
Case Studies in Medical Device Design
Real-world case studies of successful medical device design and development

Module #22
Medical Device Design Project Management
Project management principles, Agile development, and design control implementation

Module #23
Medical Device Testing and Verification
Testing and verification methods, protocols, and regulatory requirements

Module #24
Medical Device Design for Cybersecurity
Designing medical devices for cybersecurity, including risk management and threat mitigation

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

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Design of Medical Devices ( 25 Modules )

Design of Medical Devices
( 25 Modules )