In 2003 iSYSTEM’s first development tool was shipped to a medical embedded systems supplier. Since then lots of medical software has been developed, debugged, analyzed, tested and deployed using iSYSTEM’s Embedded Software Development Environment (winIDEA/testIDEA) in combination with iSYSTEM Blue Box Debugger and Analyzer Hardware.
Companies developing medical embedded software have to follow functional safety standards such IEC 62304 (Medical device - Software life cycle processes). Those standards have considerable impact on the actual medical software development process, particularly the specified test scope. iSYSTEM tools are developed to smoothly integrate in such processes, to provide debug and analyzer functionality as well as test automation capabilities. iSYSTEM‘s development and test process is transparent to customers. In addition they have access to iSYSTEM‘s regression test tool suite. This enables users to validate iSYSTEM tools operate properly in the context of a safety project as required by a standard and any additional requirements of the users project (Tool Qualification).