Radiometer Medical needed additional resources to prepare Usability Engineering planning and documentation of a new device 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
The cooperation with Radiometer is a perfect example of how we use our broad experience in the development of medical devices to help our clients with more strategic and regulatory processes in their development projects. 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.
– Allan Spork, CEO, Technolution A/S