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 terms of usability and provides information about the approach 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 medical device design process
- Analysis – understanding the context of use
- Design – translating requirements into design
- Make it tangible – make design and interaction tangible
- Testing – examining and improving design and interaction
- Standards-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.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
