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ISO 9001:2008
ISO/TS 16949:2009
Software Engineering
FDA requirements, Kit of Checklists for Medical Device Firms
ANSI/AAMI/ISO 13485:2003 Requirements Checklist
ANSI/UL 1998:2004 Checklist
IEC 60601-1-4 Checklist
IEC 62304:2006 Checklist
ISO/IEC 90003:2004 Supplier Assessment
ISO 9001:2008 Evidence Product Checklist
FDA Guide, Pre-market Submissions, Software in Medical Devices
FDA Software Validation Checklist
FDA Off-the-Shelf Software in Medical Devices, Checklist
Templates for Software and System Management
Guides to
Software Engineering
Standards
Reference
Publishing
Translations
Consulting
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ISO 9001:2008
ISO/TS 16949:2009
Software Engineering
FDA requirements, Kit of Checklists for Medical Device Firms
ANSI/AAMI/ISO 13485:2003 Requirements Checklist
ANSI/UL 1998:2004 Checklist
IEC 60601-1-4 Checklist
IEC 62304:2006 Checklist
ISO/IEC 90003:2004 Supplier Assessment
ISO 9001:2008 Evidence Product Checklist
FDA Guide, Pre-market Submissions, Software in Medical Devices
FDA Software Validation Checklist
FDA Off-the-Shelf Software in Medical Devices, Checklist
Templates for Software and System Management
Guides to
Software Engineering
Standards
Reference
Services
Publishing
Translations
Consulting
Products
Templates for Software and System Management
Template-Kit for Software Engineering Management
Templates for software configuration, documentation, maintenance. Satisfies ISO/IEC 12207, ISO/IEC 15288, IEC 62304, IEEE 14764
Download (ZIP), 4 PDF files, 2,399 KB
Item No.: RCG023CSEP, published December 2009
...more information
Templates for Software Configuration Management
Set of templates for Software Configuration Management Documents for IEC 62304, ISO/IEC 15288, ISO/IEC 12207
Download (PDF) 260 KB , 106 pages
Item No.: RCG024ASEP, Published August 2009
...more information
Template for a Software Maintenance Plan
Templare for implementation of operation and maintenance processes according to ISO/IEC 12207 and ISO/IEC 14764
Download (PDF) 277KB, 38 pages
Item No.: RCG025ASEP, published June 2008
...more information
Template for a System Documentation Mgmt. Plan
The template satisfies ISO/IEC 15288:2008, System Life Cycle Processes, Section 6.3.6
Download (PDF) 1,116 KB, 95 pages
Item No.: RCG026BSEP, published December 2009
...more information
Template for a Software Documentation Mgmt. Plan
Template for a Software Documentation Management Plan that meets the requirements of ISO/IEC 12207:2008 Clause 6.3.6.
Download (PDF) 1,330 KB, 103 pages
Item No.: RCG021BSEP, published December 2009
...more information
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