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IEC
62304:2006
Medical Device
Software- Software Life Cycle Processes
Checklist |
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Evidence
Product Checklist for the Standard
IEC 62304:2006
Medical Device Software- Software Life
Cycle Processes
by Stan Magee
E-Book 105 Pages
Published March 2007
Download (PDF) 250 KB
Item No.: RCG32SEPTISO
List Price: US $ 149.00 |
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Description
This Checklist is for the application of the 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 the standard 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 the following requirements for artifacts:
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- 77 Procedures
- 13 Plans
- 77 Records
- 42 Documents (including lists, manuals,
reports, scripts and specifications)
- 3 Audits
- 125 Reviews
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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.
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 |
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