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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
... development and commercialization processes include IEC 60601-1 and its collateral standards (related to basic product safety and performance), IEC 62366 (usability engineering), ISO 14971 (risk management), which is mandated by IEC 60601 and ISO 13485 (quality management systems for the medical device...
