Checklists for FDA and Medical Devices related standards
Checklists for FDA and Medical Devices related standards
IEC 60601-1-4
Evidence Product Checklist for the standard IEC 60601-1-4 edition 1.1 2000-04, IEC 60601-1-4: Medical Electrical Equipment Part 1: General Requirements for Safety. Part 4. - Programmable Electrical Medical Systems
ANSI/AAMI SW68
Evidence Product Checklist for the standard ANSI/AAMI SW68 - Medical Device Software- Software Life Cycle Processes
ISO/IEC 12207:2008
Evidence Product Checklist for the standard ISO/IEC 12207:2008 Software Life Cycle Processes, including Amendment 1 and Amendment 2 
ANSI/AAMI/ISO 13485:2003
Evidence Product Checklist for
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes
ANSI/UL 1998
Evidence Product Checklist for the standard ANSI/UL 1998 for Software in Programmable Components
ISO/IEC 90003:2004
Evidence Product Checklist for the standard ISO/IEC 90003:2004 Software engineering: Guidelines for the application of ISO 9001:2000 to computer software
ISO 9001:2000
 Evidence Product Checklist for Quality Management System Requirements
FDA Document “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices” September 9, 1999,
 as amended by "Guidance for Industry, FDA Reviewer and Compliance on Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software" January 14, 2005  
Evidence Product Checklist