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For Medical Devices, Checklists, Guides for FDA Related Software
 
 
 Medical Device Software Checklist Kit (DOCX) 
  Medical Device Software Checklist Kit (DOCX)
 For ISO 13485, ANSI/UL 1998, IEC 62304, ISO 9001, ISO/IEC 90003, FDA Pre-market Submissions, Software Validation, Off-the-Shelf Software, Cybersecurity
Download (zip) 5,363 KB, .docx format
Item No.: RCG056AWSEP

  ...more information   
 
 Medical Device Software Checklist Kit (PDF) 
  Medical Device Software Checklist Kit (PDF)
 For ISO 13485, ANSI/UL 1998, IEC 62304, ISO 9001, ISO/IEC 90003, FDA Pre-market Submissions, Software Validation, Off-the-Shelf Software, Cybersecurity
Download (zip) 738 KB, .pdf format
Item No.: RCG056ASEP

  ...more information   
 
 ANSI/UL 1998:2004 Checklist (MS WORD) 
  ANSI/UL 1998:2004 Checklist (MS WORD)
 Checklist for the application of the standard ANSI/UL 1998:2004 for Software in Programmable Components

Download, (MS WORD format), 558 KB, 86 pages, (also available in PDF format)
Item No.: RCG019AWSEP, published October 2004
  ...more information   
 
 IEC 62304:2006 Medical Device Software Life Cycle Processes -MSW 
  IEC 62304:2006 Medical Device Software Life Cycle Processes -MSW
 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

  ...more information   
 
 FDA 21 CFR Requirements Evidence Checklist (MS WORD) 
  FDA 21 CFR Requirements Evidence Checklist (MS WORD)
 For the standard FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, Final Rule

Download (MSWORD format), 540 KB, 31 Pages, (also available in MS WORD format)
Item No.: RCG013ARCG, published October 2001
  ...more information   
 
 Pre-market Submissions of Software in Medical Devices (MS WORD) 
  Pre-market Submissions of Software in Medical Devices (MS WORD)
 Checklist for FDA Guidance for the content of pre-market submissions for software contained in medical devices

Download, MS-WORD format, 782 KB, 83 Pages, (also available in PDF format)
Item No.: RCG012BWSEP, published March 2005
  ...more information   
 
 FDA Off-the-Shelf Software in Medical Devices (MS WORD) 
  FDA Off-the-Shelf Software in Medical Devices (MS WORD)
 Guidance for compliance with Off-the-Shelf Software Use in Medical Devices, Cybersecurity

Download, MS Word format, 556 KB, 21 pages, (also available in PDF format)
Item No.: RCG011AWSEP, published June 2005
  ...more information   
  Result Pages:  1 

 

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