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Standard

SEPT IEC 62304 Checklist

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Note: This standard has a new edition: SEPT IEC 62304 Checklist

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Abstract

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase. New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document! 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. New! Order the "Self-Extracting File Format" option to get this template in as an editable Microsoft Word document! 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 - 125 Total- 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. 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.

Document information

  • Standard from SEPT
  • Published:
  • Version: 0
  • Document type: IS
  • Pages

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