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Evidence Product Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
Synopsis
Now! The experts at SEPT have produced a checklist for the medial device Standard IEC 62304:2006 Medical Device Software Software Life Cycle Processes This checklist defines clearly the artifacts required by this standard.
This checklist was prepared by analyzing each clause of this document for the key words that signify a policy, procedure, plan, record, document, audit, or review. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The number required or suggested by this document is over 325 items. This checklist reflects these requirements for artifacts.
Artifact #
Procedure 77
Plan 13
Record 77
Document ( Including List, Manuals, Reports, Scripts and Specifications) 42
Audit 3
Review Total 125
337
The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of this standard.
Every Checklist comes with 3 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.
Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. A quality product at a reasonable price! This is an aid that will pay dividends.
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About the Author
Software Engineering Process Technology Company, (SEPT) is a firm specializing in meeting the software process standards information needs of the professional community, particularly concerning ISO/IEC 12207. SEPT was founded in 1992 by Stan Magee CCP. SEPT provides standards information via books, checklists, templates, and consulting. Mr. Magee was one of the principal US delegates in the development of ISO/IEC 12207 over the 6 years of its development.
Mr. Magee has over 50 years experience in the software field and is considered an expert in the area of software life cycle methodology. He was active on many governmental, educational and professional boards, and holds a BS from the School of Engineering from Oregon State University and an MBA in International Business from the University of Puget Sound.
"About this title" may belong to another edition of this title.
- PublisherSoftware Engineering Process Technology (SEPT)
- Publication date2007
- ISBN 10 0977030946
- ISBN 13 9780977030941
- BindingCD-ROM
- LanguageEnglish
- Number of pages105
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