Medical Device Software: A new Challenge

被引：1

作者：

Luzi, Daniela ^{[1
]}

Pecoraro, Fabrizio ^{[1
]}

机构：

[1] CNR, Inst Res Populat & Social Policies, Rome, Italy

来源：

QUALITY OF LIFE THROUGH QUALITY OF INFORMATION | 2012年 / 180卷

关键词：

Medical device software; risk management; regulatory marketing procedures; software lifecycle;

D O I：

10.3233/978-1-61499-101-4-885

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

The application of software in the medical device domain has become central to improve diagnoses and treatments. The introduction of new regulations poses issues for the qualification and classification of MD software and requires complex procedures to make them complaint with safety requirements. The paper focuses on EU, Canada and US regulations, standards and guidelines and in particular highlights the integration of the risk management process with the software lifecycle.

引用

页码：885 / 890

页数：6