Initial hazard analysis

As medical electronic devices and systems become more complex and ubiquitous, various techniques from other industries are adopted to improve device and system quality. One example is hazard analysis. Hazard analysis examines system hazards. The initial phase of one hazard analysis process for use on medical devices is described below. Proactive use of this technique as part of a product quality program can reduce hazard exposure to operators and patients, as well as expedite regulatory and agency approval