PRODUCTS
 ISO 9001 - ISO/TS 16949
Quality System Models and Implementation Tools
quality manual, procedures, flowcharts, checklists

Guides, Templates and Checklists for Software Management, Cybersecurity
ISO 90003, ISO/IEC 12207, IEEE/EIA 12207, ISO/IEC 15288, ANSI/AAMI SW68,
 IEC 60601-1-4, ANSI/UL 1998, FDA 21 CFR, ANSI/AAMI/ISO 13485:2003, ISO/IEC 27002:2005, ISO/IEC 20000-1:2005
ISO 9001:2008
ISO / TS 16949
Dictionary
Checklists, Guides, Templates 
for Software Engineering 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
FDA 21 CFR
Evidence Product Checklist for the FDA Document “FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule” 
ISO/IEC 27002:2005
Evidence Product Checklist for the standard
 Information Technology - Security Techniques -
Code of practice for information security management
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 Software Life Cycle Processes, including Amendment 1 and Amendment 2 
IEEE/EIA 12207
Evidence Product Checklist -IEEE/EIA 12207.0-1996 Industry Implementation of the International Standard ISO/IEC: 12207 Software Life Cycle Processes
ISO/IEC 15288
Evidence Product Checklist for the standard ISO/IEC 15288-System Engineering-System Life Cycle Processes 
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
ANSI/AAMI/ISO 13485:2003
Evidence Product Checklist for
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes
ISO/IEC 27002:2005
Evidence Product Checklist for ISO/IEC 27002:2005 Information Technology - information security management
ISO/IEC 20000-1:2005
Evidence Product Checklist for Information Technology –Service Management  - Part 1: Specification  
FDA document "General Principles of Software Validation
Final Guidance for Industry and FDA Staff"
Evidence Product Checklist
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 
FDA document “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices”
 Evidence Product Checklist 
Guide to Software Engineering Standards and Specifications -Part I
Software Development and Maintenance Standards
Guide to Software Engineering Standards and Specifications -Part II
Software Development Supporting Process Standards - (Configuration Management, Documentation, Project Management, Quality Assurance, and Verification and Validation Standards)
Guide to Software Engineering Standards and Specifications Part III
Software Engineering Tools and Techniques Standards - (Case Tools, Languages and Notations, Metrics, Privacy, Process Improvement, Reliability, Safety, Security, Software Reuse, and Vocabulary Standards)
Checklist-Kit for Medical Devices, for the application of software standards
Kit with 9 Checklists
Template for a System Documentation Management Plan
Includes ISO/IEC 15288, System Life Cycle Processes (2002), Section 5.4.8