Challenges of distributed risk management for medical application platforms

Abstract

ISO 14971, the primary medical device risk management standard focuses on single-manufacturer monolithic devices. However, the trend towards medical systems built from reusable platforms and interoperable components produced by different manufacturers introduces a number of additional risk management challenges. In this paper, we revisit the stages of the ISO 14971 risk management process, identify risk management challenges associated with interoperable medical systems that are not sufficiently addressed in ISO 14971, and we discuss possible process, analysis, and management concepts that may be useful in addressing these challenges.