Graphical User Interface development using Embedded Wizard and Yocto Project for an IVD device
Demeter, Leila (2023)
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202304185461
https://urn.fi/URN:NBN:fi:amk-202304185461
Tiivistelmä
The research in this thesis aims to clarify how Graphical User Interface (GUI) development differs in the In Vitro Diagnostics (IVD) field compared to fields lacking regulations and standards such as the ones guiding the processes in the life-cycle of IVD devices.
The overall life cycle of an IVD device generally consists of the following steps: Proposal, Feasibility, Development, Validation activities and Post-release Processes. Each of these phases produces documentation for the purpose of traceability and consistency, and all of these steps serve to further perfect the device until the end of its life cycle.
The most important regulations affecting the IVD field are Regulation (EU) 2017/746 (EU IVDR), ISO 13485, ISO 14971 and the IEC 62304.
The development of the GUI in this thesis project used Embedded Wizard Studio (EW) as a development tool. EW is a relatively new technology that allows the developer to create reactive GUI modules and build the infrastructure of communication between the device and the user while using the Device Class and DeviceDriver.c.
Finally, the C code generated by EW was compiled using Yocto Project creating an image that can be flashed to the target device with the UUU tool, which proved that EW is a suitable tool for GUI development and integration of an IVD device.
The overall life cycle of an IVD device generally consists of the following steps: Proposal, Feasibility, Development, Validation activities and Post-release Processes. Each of these phases produces documentation for the purpose of traceability and consistency, and all of these steps serve to further perfect the device until the end of its life cycle.
The most important regulations affecting the IVD field are Regulation (EU) 2017/746 (EU IVDR), ISO 13485, ISO 14971 and the IEC 62304.
The development of the GUI in this thesis project used Embedded Wizard Studio (EW) as a development tool. EW is a relatively new technology that allows the developer to create reactive GUI modules and build the infrastructure of communication between the device and the user while using the Device Class and DeviceDriver.c.
Finally, the C code generated by EW was compiled using Yocto Project creating an image that can be flashed to the target device with the UUU tool, which proved that EW is a suitable tool for GUI development and integration of an IVD device.