Checklist for the Standard ANSI/AAMI SW68

ISO 9000 -
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ISO 9001 Evidence Checklist

ISO/TS 16949
QS 9000

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ISO/IEC 12207
Software Life Cycle

IEEE/EIA 12207

ISO/IEC 90003:2004

ISO/IEC 9003:2004 Supplier Assessment

IEC 60601-1-4

IEC 62304:2006

ISO/IEC 20000-1:2005

ANSI/AAMI/ISO 13485:2003

ISO/IEC 27002:2005

FDA 21 CFR

ANSI/UL 1998

ISO/IEC 15288
System Life Cycle Processes

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Guides and Templates for Software Engineering

ANSI/AAMI SW68
Medical Device Software- Software Life Cycle Processes
Checklist

Evidence Product Checklist for the Standard ANSI/AAMI SW68
Medical Device Software- Software Life Cycle Processes

by Stan Magee

E-Book 108 Pages
Published November 2001
Download (PDF) 180 KB
Item No.: RCG18SEPTRCG

List Price: US $ 149.00

Description
Checklist for the standard ANSI/AAMI SW68. This checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. It identifies over 350 pieces of physical evidence. This checklist clarifies what is required for compliance with the standard by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard. For medical device firms, use of the checklist will save time and money, and may aid in meeting certain governmental requirements. The purchase of the checklist includes four hours of free consultation during 60 days after date of purchase, concerning questions about the standard and the checklist. The checklist is a quality product at a reasonable price!