Most of the MEDTEQ equipment involves software, many items involve both PC software and hardware software (firmware). Over several years more than 100,000 lines of code have been written providing insight into the complexities of software, including the common sources of bugs and software issues. Significant experience has also been obtained testing high risk medical devices such as infusion pumps, dialysis machines, surgical lasers for functional safety, which requires a detailed analysis and validation of the critical hardware and software protection systems.
In addition, during the development of the MEDTEQ HFIT, documents were prepared in accordance with IEC 62304 with the object of learning more about practical implementation of the standard. This process created many "light bulb" moments where the common understanding of design life cycle, architecture, specifications, verification and validation were found to be wrong when the real text of the standard was closely checked, and also viewed from a regulatory or legal perspective. Moreover, many of old common understandings, while made with good intentions, actually add significant risk to the process, yielding less safe and effective medical devices.
With this new understanding coupled with the experience of actual design, the following guidance is provided for specific subjects in the standard.
Classification / Design life cycle / Architecture / Specifications
Validation (and verification) / Legacy software
General approach to IEC 62304