Column: Standards Outlook: Ensure Medical Device Safety

Article

Schnoll, Les   (2002, ASQ)   Hill-Rom Co., Batesville, IN;

Quality Progress    Vol. 36    No. 2
QICID: 18840    February 2003    pp. 73-75
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Article Abstract

[Abstract from article]

To achieve compliance with one of the key components of national and international regulatory requirements, companies must develop, implement and maintain an effective risk management process that identifies potential hazards associated with the use of their medical devices.

In addition to ensuring proper sanitary conditions, sterilization (when appropriate) and general cleanliness, a risk management program is a critical necessity to a robust regulatory compliance program. In the medical device world, such a program should be based on an accepted set of principles and guidelines, such as ISO 14971. This international standard, published in 2000, is a valuable tool that helps a manufacturer determine the safety of its products.

Keywords

Biomedical


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