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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
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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
Guides to
Software Engineering
Standards
Guide to Software Engineering Standards -Part I
For Software Development and Maintenance Standards and Specifications
Download (PDF) 345 KB, 123 Pages
Item No.: RCG004ASEP, published December 1999
...more information
Guide to Software Engineering Standards -Part II
Case Tools, Metrics, Privacy, Process Improvement, Reliability, Safety, Software Reuse, Vocabulary Standards
Download (PDF) 462 KB, 158 Pages
Item No.: RCG005ASEP, published December 1999
...more information
Guide to Software Engineering Standards -Part III
Configuration, Documentation and Project Management, Quality Assurance, Verification and Validation Standards
Download (PDF) 529 KB, 181 Pages
Item No.: RCG006ASEP, published December 1999
...more information
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