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Keywords: Medical device
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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...
