In this module the learner is introduced to the design and development of medical devices in a controlled and regulated environment. The learner will appreciate the importance of identifying user and market needs and apply these tools in the design of a medical device. The design process implemented will follow industry standards and the learner will document the design following design control processes encouraged by regulators. The learner will be formally introduced to device classification, applicable standards and the importance of human factors in device design.
- What is a medical device?
- Where do ideas for new devices come from?
- Preparing a Design Brief.
- Medical Device Design Control Process.
- Documenting the Design History.
- Introduction to Medical Device Classification.
- Human Factors in Medical Devices.
- Design Verification and Validation.
