1. Principles of user-centered design, ideation, prototyping, testing, and commercialization.
2. Overview of quality management systems, risk management and regulatory requirements, including US FDA regulations and the EU Medical Device Regulation.
3. Overview of regulations governing medical devices in major international markets, including China, Japan and Australia. Strategies for obtaining regulatory approval and ensuring compliance in global markets.
4. Overview of business and financial aspects of medical device development, including market analysis, intellectual property and commercialization strategies.
5. Strategies for entrepreneurship and innovation in the medical device industry, including how to identify market opportunities, secure funding and bring product to market
6. Definition and evaluation of the supply chain for medical devices, including outsourcing, manufacturing, logistics and distribution. Considerations for supply chain risk management and quality and safety assurance.
7. Overview of design controls used in medical device development, including design input, design output, design verification, design verification, and design transfer.
8. Overview of health literacy and its role in the development of medical devices, including designing medical devices that are easy to understand and use by patients with different levels of health literacy.
9. Strategies for effective collaboration and teamwork in the development of medical devices, including project management, team dynamics and communication.
10. Overview of patient involvement in medical device development, including the importance of involving patients in the design process, understanding their needs and preferences, and incorporating their feedback into the development process.
11. An overview of project management principles and best practices, including planning, scheduling, budgeting, risk management, and stakeholder management.
12. Overview of the impact of medical devices on the environment and strategies for designing ecologically sustainable medical devices.
13. User interface design – user awareness, user manuals, signage
14. Overview of new areas in the development of medical devices, such as wearable medical devices, mobile medical applications and digital health technologies. A discussion of their impact on the medical device industry and their potential to improve patient care.
2. Overview of quality management systems, risk management and regulatory requirements, including US FDA regulations and the EU Medical Device Regulation.
3. Overview of regulations governing medical devices in major international markets, including China, Japan and Australia. Strategies for obtaining regulatory approval and ensuring compliance in global markets.
4. Overview of business and financial aspects of medical device development, including market analysis, intellectual property and commercialization strategies.
5. Strategies for entrepreneurship and innovation in the medical device industry, including how to identify market opportunities, secure funding and bring product to market
6. Definition and evaluation of the supply chain for medical devices, including outsourcing, manufacturing, logistics and distribution. Considerations for supply chain risk management and quality and safety assurance.
7. Overview of design controls used in medical device development, including design input, design output, design verification, design verification, and design transfer.
8. Overview of health literacy and its role in the development of medical devices, including designing medical devices that are easy to understand and use by patients with different levels of health literacy.
9. Strategies for effective collaboration and teamwork in the development of medical devices, including project management, team dynamics and communication.
10. Overview of patient involvement in medical device development, including the importance of involving patients in the design process, understanding their needs and preferences, and incorporating their feedback into the development process.
11. An overview of project management principles and best practices, including planning, scheduling, budgeting, risk management, and stakeholder management.
12. Overview of the impact of medical devices on the environment and strategies for designing ecologically sustainable medical devices.
13. User interface design – user awareness, user manuals, signage
14. Overview of new areas in the development of medical devices, such as wearable medical devices, mobile medical applications and digital health technologies. A discussion of their impact on the medical device industry and their potential to improve patient care.