Medical/Safety Software: Tools and Techniques
Developing software for medical and safety-critical systems can seem like a daunting task to a project team. Much of this apprehension can be attributed to the additional overhead required by these projects in order to meet safety regulations, gain FDA approval, and so on. This paper explores the additional tasks common to safety-critical systems, and provides examples that have been used successfully in real projects. Some of these tasks include: how to implement risk/hazard analyses, how and when to perform a fault tree analysis, managing traceability throughout a project, and maintaining accurate revision level history while incorporating change requests. Fitting these extra tasks into a project schedule, estimating how much effort they require, and avoiding common mistakes are discussed throughout the paper.