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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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-03-01
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| Series: | Journal of Open Innovation: Technology, Market and Complexity |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2199853124002336 |
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