Our clients are experiencing still increasing regulatory requirements, and we are pleased that we are able to assist our clients market their solutions quickly and correctly in this area too.
Radiometer needed additional resources to prepare Usability Engineering planning and documentation of a new solution to meet the IEC 62366th standard.
In addition, the applied processes and documentation was to be used for the approval of similar solutions within the product family.
These activities were carried out in close cooperation with Radiometer’s development, quality and marketing departments, and it was expected that Technolution participated as a natural part of Radiometer’s development team.
Technolution prepared the usability engineering documents and assisted with the update of the product requirements specification and risk analysis. Usability Engineering File:
- Usability Engineering File Index
- Usability Use Scenarios
- Training and Material for Training
- Usability Verification Plan
- Usability Validation Plan
- Usability Verification Protocol
- Usability Validation Protocol
- Usability Verification Report (draft)
- Usability Validation Report (draft)
The final documentation will be part of Radiometer Medical’s CE marking of the product and will provide the basis of equivalent approval of all variants of capillaries.
Technolution prepared the reports for documentation of the tests, which Radiometer Medical implemented according to the stated protocols.
Radiometer Medical gained the following by working with Technolution:
- Quicker approval of the product by adding competences
- Basis for approval of other products
Technolution has a unique combinationSee our competences
Click here to see what we offer. of resources that enable us to contribute to all phases of the project.
The implementation of usability engineering requires both technological insight, understanding of user and usage scenarios as well as Project Management.