Evidence Product Checklist for IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes
Download, MS WORD format, 1,522 KB, 105 pages (also available in PDF format), Item No.: RCG014AWSEP, Published March 2007
This Checklist is for the application of 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 these requirements for artifacts.
42 Documents (Including Lists, Manuals, Reports, Scripts and Specifications)
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!