One of the challenges in developing the new generation of measuring equipment was the growing demands on medical device software according to IEC norm 62304 and MDR (medical device regulation), which has been compulsory in the EU since 2021, as well as the requirements of the American Food and Drug Administration (FDA). At the same time, the demands on security compliance in hospitals have increased.
To ensure norm-compliant development of the underlying embedded Linux system and a high level of security throughout the entire life cycle, PTW has relied on the expertise, tools and processes of emlix GmbH for many years.
The UNIDOS embedded Linux platform is the result of intensive development cooperation between PTW and emlix. In order to fulfil the extensive requirements of the norms over the entire product life cycle, e2factory is used as the software management and build automation tool. Automation and reproducibility of tests are ensured using the emlix TAF test application framework.
In the operating and maintenance phase, emlix is responsible for the maintenance and security monitoring. As a result, relevant security issues, new software versions and improvements to relevant components can be identified promptly.
The system architecture of the UNIDOS embedded Linux platform was specified by emlix in close coordination with PTW. The main design target was a norm-compliant, centrally maintainable embedded Linux platform.
In addition to a graphical user interface (GUI) for the fully integrated display with capacitive touch functionality, audio output is supported. The system family is networked via LAN and WLAN, so that easy operation is possible via PC, laptop or smartphone.
Using a camera, UNIDOS Tango can read QR codes on PTW measurement detectors. Detector-specific information (including calibration factor and date) can be read into the detector database in the dosimeter automatically using a 2D code scanner.
The system platform for PTW UNIDOS also has an intrusion detection system (IDS). The IDS constantly monitors the system integrity and the network traffic in order to identify possible attacks.