Medical Devices
Course Title: Medical Devices
Course Description: This course is designed to provide students with an introduction to the principles and practices of medical device development. The course covers topics such as medical device regulations, design controls, risk management, and testing. The course also introduces students to the various types of medical devices and their applications in healthcare.
Course Objectives:
Understand the principles and regulations governing medical devices
Learn the basics of medical device design and development
Understand the importance of risk management in medical device development
Learn the testing and validation processes for medical devices
Understand the various types of medical devices and their applications in healthcare
Course Outline:
Week 1: Introduction to Medical Devices
Introduction to the course and medical devices
Overview of the medical device industry
Medical device regulations and standards
Week 2: Medical Device Design Controls
Design and development process
Design controls and documentation
Design verification and validation
Week 3: Risk Management in Medical Devices
Introduction to risk management
Risk analysis and assessment
Risk control and mitigation
Week 4: Testing and Validation of Medical Devices
Introduction to testing and validation
Types of testing and validation
Acceptance criteria and documentation
Week 5: Types of Medical Devices
Diagnostic and therapeutic devices
Implants and prosthetics
Wearable and connected devices
Week 6: Applications of Medical Devices in Healthcare
Medical device integration in healthcare
Telemedicine and remote patient monitoring
Ethical considerations in medical device development