PRODUCTS
ISO 9000 -  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 9000 - ISO 9001
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
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
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 10 Checklists
Template for a System Documentation Management Plan
Includes ISO/IEC 15288, System Life Cycle Processes (2002), Section 5.4.8