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Product Overview - Quality Management - Software Engineering
ISO 9001 Quality Management Development Tools
ISO/IEC 27001:2013 - Security Requirements
ISO/IEC 27001:2017 - Software Security Requirements
ISO/IEC 27002:2013 Security Code of Practice
ISO/IEC 27018:2014 - Security Management
Software Security ISO/IEC 27001, ISO/IEC 27002, ISO/IEC 27018
For Medical Devices, Checklists, Guides for FDA Related Software
ISO 13485:2016 - Medical Devices, Software Requirements
ISO 9003 - ISO/IEC 90003
ISO 9004:2009 for a Successful Quality Management Approach
IEC 62304:2015 Medical Device Software - Life Cycle Process
ISO/TS 16949:2009 Documentation Model, Requirements Checklist
FDA Software Validation
System and Software Engineering, Tools, Guides, Checklists
Templates for Software Configuration Mgmt. and Maintenance
Templates for System - Software - Document Management
Guide to Software Eng. Standards Development and Maintenance
ISO/IEC 15288:2008 Compliance
ISO/IEC 20000-1:2011 Information Technology
FDA 21 CFR Compliance Requirements
ISO/IEC/IEEE 42010:2011 - Architecture Description Checklist
FDA Off-the-Shelf Software in Medical Devices
Quality Software Standard Checklist Kit
ANSI/UL 1998:2004 Compliance Guide
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Product Overview - Quality Management - Software Engineering
ISO 9001 Quality Management Development Tools
ISO/IEC 27001:2013 - Security Requirements
ISO/IEC 27001:2017 - Software Security Requirements
ISO/IEC 27002:2013 Security Code of Practice
ISO/IEC 27018:2014 - Security Management
Software Security ISO/IEC 27001, ISO/IEC 27002, ISO/IEC 27018
For Medical Devices, Checklists, Guides for FDA Related Software
ISO 13485:2016 - Medical Devices, Software Requirements
ISO 9003 - ISO/IEC 90003
ISO 9004:2009 for a Successful Quality Management Approach
IEC 62304:2015 Medical Device Software - Life Cycle Process
ISO/TS 16949:2009 Documentation Model, Requirements Checklist
FDA Software Validation
System and Software Engineering, Tools, Guides, Checklists
Templates for Software Configuration Mgmt. and Maintenance
Templates for System - Software - Document Management
Guide to Software Eng. Standards Development and Maintenance
ISO/IEC 15288:2008 Compliance
ISO/IEC 20000-1:2011 Information Technology
FDA 21 CFR Compliance Requirements
ISO/IEC/IEEE 42010:2011 - Architecture Description Checklist
FDA Off-the-Shelf Software in Medical Devices
Quality Software Standard Checklist Kit
ANSI/UL 1998:2004 Compliance Guide
Reference
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Publishing
Translations
Consulting
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For Medical Devices, Checklists, Guides for FDA Related Software
Medical Device Software Checklist Kit (DOCX)
Medical Device Software Checklist Kit (DOCX)
...more information
Medical Device Software Checklist Kit (PDF)
Medical Device Software Checklist Kit (PDF)
...more information
ANSI/UL 1998:2004 Checklist (MS WORD)
ANSI/UL 1998:2004 Checklist (MS WORD)
...more information
IEC 62304:2006 Medical Device Software Life Cycle Processes -MSW
IEC 62304:2006 Medical Device Software Life Cycle Processes -MSW
...more information
FDA 21 CFR Requirements Evidence Checklist (MS WORD)
FDA 21 CFR Requirements Evidence Checklist (MS WORD)
...more information
Pre-market Submissions of Software in Medical Devices (MS WORD)
Pre-market Submissions of Software in Medical Devices (MS WORD)
...more information
FDA Off-the-Shelf Software in Medical Devices (MS WORD)
FDA Off-the-Shelf Software in Medical Devices (MS WORD)
...more information
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Wednesday 20 February, 2019
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Medical Device Software Checklist Kit (DOCX)
