Integrating Failure Mode Effect Analysis into the Medical Device Approval Process

Authors

Gerhard Steinke, Seattle Pacific University
Vania Kurniawati, Seattle Pacific University
Jim Nindel-Edwards, Globys Corporation

Abstract

Medical devices that utilize computer software are becoming common place in today’s health care environment. Device failures can have life threatening consequences. The medical device approval process issued by the FDA should enhance the software testing requirements. In this paper we suggest that Failure Mode Effect Analysis (FEMA) should be a standard component in the testing of software in medical devices that can have life threatening consequences.

Recommended Citation

Steinke, Gerhard; Kurniawati, Vania; and Nindel-Edwards, Jim (2010) "Integrating Failure Mode Effect Analysis into the Medical Device Approval Process," Communications of the IIMA: Vol. 10: Iss. 3, Article 4.
DOI: https://doi.org/10.58729/1941-6687.1142
Available at: https://scholarworks.lib.csusb.edu/ciima/vol10/iss3/4