Failure mode effect analysis use and limitations in medical device risk management

This study aims to investigate the application of risk analysis techniques in the medical device industry and the techniques most utilised to address compliance with ISO 14971:2019 with a view to assessing the challenges of risk management. Failure Mode Effect Analysis (FMEA) and its limitations as...

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Bibliographic Details

Published in:	Journal of Open Innovation: Technology, Market and Complexity
Main Authors:	Niamh Nolan, Olivia McDermott
Format:	Article
Language:	English
Published:	Elsevier 2025-03-01
Subjects:	Risk management Medical device ISO 14971 Failure mode and effect analysis (FMEA) Risk analysis
Online Access:	http://www.sciencedirect.com/science/article/pii/S2199853124002336