Integrating a Risk-based Approach and ISO 62304 into a Quality System for Medical Devices

被引：0
|
作者：
Bianco, Celestina [1 ]
机构：
[1] Systelab Technol, Barcelona, Spain
来源：
ADVANCES IN SYSTEMS SAFETY | 2011年
关键词：
D O I：
10.1007/978-0-85729-133-2_7
中图分类号：
TP [自动化技术、计算机技术];
学科分类号：
0812 ;
摘要：
A recent standard for medical device software lifecycle processes, ISO/IEC 62304 (ISO 2006), assumes and specifies a software safety classification scheme, where documentation, verification and validation tasks to be carried out depend on the safety classification. This means that a risk-driven approach has become an accepted standard for medical devices. This paper describes how Systelab have progressively defined a quality system that integrates as core processes those specified by ISO 62304, and that applies a risk-driven approach also supporting processes such as contract and supplier management.
引用
收藏
页码：111 / 125
页数：15
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