In most cases, the core of a medical device is its software. In addition to the software that drives the device such as Embedded SW and Firmware, aspects like usability (UI), connectivity (WLAN, Bluetooth, LTE/5G) and other remote monitoring requirements, cyber security and IoT-capacity are becoming more and more important.
Mobile device apps, web-based cloud-solutions and integrative hospital systems (KIS) as well as lab information systems (LIS) must be considered, too.
The growing complexity of modern software has to be dealt with safely, especially when it comes to medical devices. Medical software has to be in compliance with the essential requirements defined in IEC 62304.
For all these reasons, we consistently work with requirement engineering, software classification, software architecture, risk analysis, and test strategies.
That is how we make sure that, in order to accomplish the project, there is a software code and that the regulatory documentation is completed.
What this means: taking care of software
security from the start.