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2011 Edition, November 29, 2011

Complete Document

Software Engineering Process Technology - Evidence Product Checklist For FDA Guidance For The Content Of Premarket Submissions For Software Contained In Medical Devices

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Product Details:

  • Revision: 2011 Edition, November 29, 2011
  • Published Date: November 29, 2011
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Software Engineering Process Technology (SEPT)
  • Page Count: 84
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

General Principles of the checklist "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" This checklist was prepared by analyzing each clause of this guidelines for the keywords that signify a: Procedure Plan Records Document (Including Lists, Manuals, Reports, Scripts and Specification) Audit Review This checklist specifies evidence that is unique. After reviewing the completed guidelines, the second review was conducted from a common sense "reasonable man" approach. If a document or other piece of evidence appeared to be recommended, but was not called out in the guideline, then it is added with an asterisk (*) after otw notation in the checklist. The information was trasferred into the checklist tables, based on the type of product or evidence.