Biomedical instrumentation & technology / Association for the Advancement of Medical Instrumentation
-
Biomed Instrum Technol · Sep 2017
Principles and Benefits of Explicitly Designed Medical Device Safety Architecture.
The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. ⋯ This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.