Module 1 provides an overview of medical device research, development and verification processes in order to provide understanding of the regulatory environment.
Learning objectives
Module 1 teaches participants to understand the different phases in the undertaking during the development of medical devices, the design process and its constraints, the process involved in design verification, validation and evaluation, and they see the importence of the design process to medical device regulatory affairs and quality management.
Learning content
It includes the introduction to the design and development process, development models and project planning, as well as product specification and design inputs. It further contains the medical device design, verification and validation, and the design and development process output.
Start & Duration
Module 1 starts in August each year.
The completion takes approximately 4 weeks.
Credits
2 ECTS
Fee
The cost of this standalone module is 2'100.– SFr.
Reference
03.001