box Platform: Verification and Validation on Schedule
Device Performance, Functionality and Safety Under Scrutiny
Development of the box device platform is progressing according to plan. A team of 22 engineers is currently focused on the final verification and validation of the hospital version.
This phase of the project is essential not only for preparing the device for clinical use and regulatory approval, but also for preparing for production. The detailed tests conducted at this stage verify that the device meets its defined requirements for safety, functionality and performance.
Three device variants are currently planned for the box platform: a hospital version, a neonatal version and a transport version. The hospital version is the first focus of the current development work.
Can box Run Fault-Free for 100 Hours?
Following the successful electromagnetic compatibility (EMC) and splash-water protection tests, further laboratory testing is under way. In parallel, the first 100-hour burn-in test is being conducted. This test assesses device behaviour during a prolonged period of uninterrupted operation.
At a later stage, the burn-in test will be supplemented by a long-term endurance test. This will assess the reliability and stability of the box platform under defined conditions over an extended period.
Next Milestones
Alongside technical verification and validation, IMT Innovations is preparing the next phase of production transfer. The forthcoming milestones include the first training session on establishing production for box licensees, as well as the setup of the first production line for an initial box licensee.
This lays the foundation for transferring the box platform into manufacturing in a structured way. Licensees receive not only access to the device technology, but also support in establishing production processes and managing the technology transfer.
Production Preparation
The box project remains on schedule. IMT Innovations will continue to advance development, verification and validation activities, and the preparation for production transfer. We will keep you informed of further progress on the box platform.
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