For an OEM in the digital health sector, a team put together specifically for the customer took on tasks in application development for a medical device.
The team was responsible for developing UI-driven workflow components for dedicated applications, controlling additional hardware applications, and adapting measurement processes.
A special feature of the work was the cross-product line coordination with software project partners. Due to the project structure, consultations with representatives from other specialist areas were necessary, including close technical exchanges with international interfaces. In addition, extensive interface clarifications with software suppliers were required. Technical decisions regarding software development were made in consultation with architects and project managers as well as in daily scrums.
All work was carried out in accordance with the regulatory requirements for medical technology. The following standards were applied: ISO 13485 (quality management systems for medical devices), IEC 62304 (medical device software – software life cycle processes) and AMD1:2015.
sepp.med brought its extensive experience in dealing with regulated medical technology software processes to this project, combined with an agile approach. The team was thus able to quickly adapt an agile process based on a process model that takes into account IEC 62304:2006, AMD1:2015, and ISO 13485:2016.
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