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- Title
Dissecting the Details.
- Authors
Mehta, Bob
- Abstract
The article discusses risk management implications of Europäische Norm (EN) International Organisation for Standardisation (ISO) 14971:2012 Medical Devices. Application of risk to medical devices standard by the U.S. Food & Drug Administration. Topics discussed include the standard applying risk management in patient's safety while using medical devices, the medical device manufacturers to develop safe and effective medical devices and estimating risks through external quality assessments.
- Subjects
INTERNATIONAL Organization for Standardization; MEDICAL equipment standards; UNITED States. Food &; Drug Administration; MEDICAL equipment design; MEDICAL equipment industry; RISK management in health facilities
- Publication
Quality Progress, 2015, Vol 48, Issue 1, p30
- ISSN
0033-524X
- Publication type
Article