Module 1 provides an overview of medical device research, development and verification processes in order to provide understanding of the regulatory environment.
Learning objectives
- To understand the different phases in the undertaken during the development of medical devices
- To understand the design process and its constraints
- To Understand the processes involved in design verification, validation and evaluation
- To understand the importance of the design process to medical device regulatory affairs and quality management
Learning content
- Introduction to the design and development process
- Development models and project planning
- Product specification and design inputs
- Medical device design, verification and validation
- Design and development process output
