| IEC 62304 Ed. 1.0 b:2006, Medical device software - Software life cycle processes |  | Author: IEC TC/SC 62A
Publisher: Multiple. Distributed through American National Standards Institute (ANSI)
Category: Book
Buy New: $278.00
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Sales Rank: 4,163,042
Language: English (Published)
Media: Paperback
Pages: 164
Shipping Weight (lbs): 1
Dimensions (in): 10.5 x 8.3 x 0.4
ASIN: B000XYSCH6
Publication Date: August 19, 2007
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Product Description
Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.
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