content
The safe and economical use of medical devices in diagnostics and therapy requires a high level of usability and optimal risk management. In order to avoid operating errors and increase the safety of medical devices, DIN EN 62366-1:2021-08 requires users to be involved in the development process. The standard obliges manufacturers of medical devices and in-vitro diagnostics to carry out a usability engineering process and document it in a usability engineering file. The seminar introduces the terminology of usability and provides information about the procedure required by the standard in the development process as well as the accompanying documentation using the usability file.
topic overview
- Introduction, terms and definitions (ergonomics, usability, user-friendliness, usability, user experience, etc.)
- Regulatory requirements, norms and standards that affect the development of medical devices
- Process for designing usable systems and principles of dialogue design DIN EN ISO 9241-210 and DIN EN ISO 9241-110
- The standard DIN EN 62366-1:2021-08 and link to DIN EN 60601-1-6
- The 4 phases of the user-centered design process for medical devices
- Analysis – understand the context of usage
- Design – converting requirements into design
- Make it tangible – make design and interaction tangible
- Testing – examine and improve design and interaction
- Standard-compliant documentation (usability engineering file)
- Linking usability and risk management
target group
Employees in the development of medical products that fall under DIN EN 62366-1:2021-08.
previous knowledge
Not mandatory.
KONTAKT:
Online
