Software quality assurance and system safety

The medical field is faced with the increasing sophistication of software-controlled medical equipment. Clinical engineers must understand and become familiar with these sophisticated software-driven medical devices and stand-alone medical software programs in order to evaluate their suitability for the desired purpose. They must be able to assess the nature of the software, its potential and its risks. Numerous aspects of software development and safety must be considered when developing and/or evaluating such software devices and programs.