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Keywords: ISO 14971
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Journal Articles
International Journal of Quality & Reliability Management (2026) 43 (5): 1439–1463.
Published: 30 March 2026
...Niamh Nolan; Olivia McDermott Purpose This study investigates current challenges in implementing risk management in the medical device industry. It focuses on the application of ISO 14971:2019 as a framework to achieve global regulatory compliance. In the European Union (EU), the harmonized...
Journal Articles
Yasmin Silva Martins Xavier, Carlos Eduardo Sanches da Silva, Paulo Sampaio, Juliana Helena Daroz Gaudencio
International Journal of Quality & Reliability Management (2026) 43 (1): 59–81.
Published: 26 June 2025
... Emerald Publishing Limited 2025 Emerald Publishing Limited Licensed re-use rights only Management systems Quality management Case studies ISO 9001 ISO 13485 ISO 14971 Despite their significant role in job creation and their substantial social, economic and scientific contributions...
