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Software Engineering
guides, templates, checklists for software development
and for the application of software engineering standards to computer software
 

For
Software System Management
Template Kit

 

For the application of 
IEC 60601-1-4, FDA 21 CFR, IEC 62304, ISO/IEC 12207,
ISO/IEC 15288, Cybersecurity, ANSI/UL 1998, ISO/IEC 27002
IEEE/EIA 12207.0, ANSI/AAMI/ISO 13485

ISO 9001, ISO/IEC 90003
guides - templates - checklists

  

For
Medical Device Firms
Medical Device Checklist Kit

Checklists for the application of software engineering standards
ISO/IEC 27002:2005
Evidence Product Checklist for the standard
 Information Technology - Security Techniques -
Code of practice for information security management
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” 
IEC 62304:2006
Evidence Product Checklist for the standard IEC 62304:2006 - 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 
ISO/IEC 15288
Evidence Product Checklist for the standard ISO/IEC 15288-System Engineering-System Life Cycle Processes 
ISO 9001:2000
Evidence Product Checklist for the standard ISO 9001:2000 Quality Management – Requirements
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/IEC 90003:2004
Supplier Assessment Checklist for the evaluation of software regarding compliance with the standard ISO/IEC 90003:2004 
IEEE/EIA 12207.0-1996
Evidence Product Checklist -IEEE/EIA 12207.0-1996 Industry Implementation of the International Standard ISO/IEC: 12207 Software Life Cycle Processes
ANSI/AAMI/ISO 13485:2003
Evidence Product Checklist for
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes
Evidence Product Checklist for the FDA Document “General Principles of Software Validation” Final Guidance for Industry and FDA staff’
Evidence Product Checklist for the FDA Document “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices", incl. "Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software
Evidence Product Checklist for the FDA Document “Guidance for the Content of  Pre-market Submissions for Software Contained in Medical Devices”
Guides to software engineering standards, templates for documentation development, etc.
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)
Template for Software Configuration Management Documents - Standard Version
Templates for Software Configuration Management Documents - Deluxe Version 3.0
Template for a Software Maintenance Plan
(ISO/IEC 12207, ISO/IEC 14764)
Template for a Software Documentation Management Plan 
Template for a System Documentation Management Plan
Includes ISO/IEC 15288, System Life Cycle Processes (2002), Section 5.4.8 
Checklists for Medical Device Firms
for the application of 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
IEC 62304:2006
Evidence Product Checklist for the standard IEC 62304:2006 - 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 
ANSI/UL 1998
Evidence Product Checklist for the standard ANSI/UL 1998 for Software in Programmable Components
Evidence Product Checklist for the FDA Document “General Principles of Software Validation” Final Guidance for Industry and FDA staff’ - Release date January 11, 2002
Evidence Product Checklist for the FDA Document “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”, , incl. "Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software
Evidence Product Checklist for the FDA Document “Guidance for the Content of   Pre-market Submissions for Software Contained in Medical Devices”
Evidence Product Checklist for
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes
ISO 9001:2000
Evidence Product Checklist for the standard ISO 9001:2000 Quality Management – Requirements
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
 

 
 

 
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