This systematic literature review how manufacturers implement ISO 14971, the international standard for medical device risk management. After almost 30 years, since the initial publication of the standard, the need for a SLR has become evident. The motivation for this study stems from the essential role medical devices play in healthcare systems and the growing emphasis on patient safety and regulatory compliance. By analysing existing literature, this review aims to identify key factors that influence the effective adoption of ISO 14971 and provide insights to support manufacturers, regulators, and stakeholders in improving risk management practices across the medical device industry.
Risk Management in Medical Devices: a Systematic Literature Review on ISO 14971
Antea MontePrimo
;Elisabetta OcelloSecondo
;Matteo PodreccaPenultimo
;Marco SartorUltimo
2025-01-01
Abstract
This systematic literature review how manufacturers implement ISO 14971, the international standard for medical device risk management. After almost 30 years, since the initial publication of the standard, the need for a SLR has become evident. The motivation for this study stems from the essential role medical devices play in healthcare systems and the growing emphasis on patient safety and regulatory compliance. By analysing existing literature, this review aims to identify key factors that influence the effective adoption of ISO 14971 and provide insights to support manufacturers, regulators, and stakeholders in improving risk management practices across the medical device industry.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
