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.

Evidence Product Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes

Stan Magee CCP

Reference

Software Engineering Process Technology (SEPT)

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Evidence Product Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes