With avaUsability, you can improve the usability of your products through digital documentation of usability engineering activities.
Audit-tested, IEC 62366-1 compliant templates help you to systematically identify the potential for improvement of device usability and integrate this directly into risk management and product development documentation.
By linking the content of the usability file with information from risk management and development, it is ensured that the content of these processes is consistent.
Links between information in the usability, risk management, and development processes are automatically displayed in the usability engineering file to ensure complete traceability for product submission or during audits/inspections.
Safety-related use scenarios and tasks are automatically included in the Summative Evaluation Plan. They can be excluded with an appropriate justification or supplemented with further use scenarios and tasks if required.
Overview of the features:
- IEC 62366-1 compliant documentation of usability engineering activities
- Templates for Usability File, Use Specification, Use Scenario Specification, Use Scenario & Task Analysis, Plan and Report for formative/summative evaluations
- Easy integration of information from other development documents
- LiveReport Page for the documentation of Use Scenario & Task Analysis
- Manual selection of Use Scenarios/User Tasks for formative evaluations
- Linking of use errors with risk analysis and design input requirements
- Visualization of the complete traceability between use errors and risks as well as use errors and user interface requirements/specifications
- Automatic pre-selection of Use Scenarios and User Tasks for summative evaluations and display in the summative evaluation plan
For more information about avaUsability, please use the following link:
https://www.avasis.biz/en/solutions/avasis-solutions/polarion-medical-device-solutions/avausability
The avaUsability is a commercial extension, trial versions can be requested via e-mail. Please write to polarion@avasis.biz or use the contact form on our homepage at https://www.avasis.biz/en.
