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- Title
Standard Comparison: Assessing risk management processes for regulated health industries.
- Authors
Wright, Carolyn
- Abstract
The article focuses on prevalence of quality standards for medical devices as risk management standards. Topics discussed include introduction of the ISO 14971 by the International Organization for Standardization (ISO); deployment of standards by the healthcare industries for risk management services related to medical devices; and comparison of ISO 14971 standard with the ICH Q9 of the International Conference on Harmonization (ICH) for risk assessment.
- Subjects
MEDICAL equipment standards; ISO 14000 Series Standards; INTERNATIONAL Organization for Standardization; RISK management in the health care industry; INTERNATIONAL Conference on Harmonisation; RISK assessment
- Publication
Quality Progress, 2017, Vol 50, Issue 6, p30
- ISSN
0033-524X
- Publication type
Article