Kit of Checklists

for
Medical Device Firms


For standards ANSI/AAMI/ISO 13485:2003, ANSI/UL 1998:2004, IEC 60601-1-4 1.1 2000-04, IEC 62304:2006, 
ISO 9001:2008, ISO/IEC 90003:2004,
 and FDA Guides for Software of Medical Devices

 

Descriptions and Sample Pages

Kit of Checklists  more information
Savings of $ 47% of normal retail price; includes 36 hours of free consultation

Please use the following links for more information and sample pages:

  • Checklist for FDA “General Principles of Software Validation”, edition 2002. See more information
  • Checklist for FDA “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices”, edition 2005. See more information
  •  Checklist for FDA “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices” as amended by Guidance for Industry, FDA Reviewers and Compliance on Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software, January 14, 2005. See more information