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Checklists, Templates and Guides for Software Engineering

For Software Engineering Standards

IEC 60601-1-4, FDA 21 CFR, ANSI/AAMI SW68, ISO 90003, 
ANSI/AAMI/ISO 13485, ANSI/UL 1998, ISO/IEC 90003,
IEC 62304, ISO/IEC 27002,  ISO/IEC 20000-1, ISO/IEC 15288,
ISO 9001, ISO/IEC 12207,

checklists, templates and guides 
for software development of applicable standards


Software Engineering Standards
The implementation of software engineering standards and the compliance with the standard’s requirements can often be very time consuming. Using available checklists, guides and templates will save time and money, and assists in meeting the requirements of the applicable standards.


Useful tools and guides for software development and compliance with international standards
Guides, checklists and templates for software engineering standards and specifications do assist with the fundamental software development that meets the requirements of applicable standards. This includes software development and maintenance, configuration management, documentation development, project management, quality assurance, verification and validation of standard requirements, case tools, languages and notations, metrics, privacy, process improvement, reliability, safety, security, software reuse, and vocabulary standards.

Using available  tools such as checklists, templates and guides for the development of software that meets the requirements of applicable standards saves time and assists that requirements are met.   

For FDA related standards and Medical Device Firms:
IEC 62304:2015 Medical Device Software – Software Life Cycle Processes ... see more information 
ISO/IEC 12207: 2008 System and software engineering - Software life cycle processes  ... see more information
ANSI/UL 1998-2004 Standard for Software in Programmable Components ... see more information   
FDA Document “General Principles of Software Validation” Final Guidance for Industry and FDA staff’ ... see more information
FDA Document “Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices” ... see more information
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes ... see more information
ISO 9001:2015 Quality Management – Requirements ... see more information
ISO/IEC 90003:2004 Software engineering: Guidelines for the application of ISO 9001:2000 to computer software ... see more information
FDA Document “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices ... see more information 

Templates, checklists and guides for software documentation development in compliance with applicable standards
Set of Templates for Software Configuration Management Documents - Version 6.0. Compliance with IEC 62304, ISO/IEC 15288, ISO/IEC 12207, ANSI/EIA-649-B ... more information
Template for a Software Maintenance Plan (ISO/IEC 12207, ISO/IEC 14764... more information
Template for a Software Documentation Management Plan ... more information
Template for a System Documentation Management Plan, includes ISO/IEC 15288, System Life Cycle Processes (2002), Section 5.4.8 ... more information
FDA 21 CFR Part 11 Electronic Records; Electronic Signatures ... more information
ISO/IEC 90003:2004
Supplier Assessment Checklist for the evaluation of software regarding compliance with the standard ISO/IEC 90003:2004 
... more information
ISO/IEC 27002:2005 information technology – security techniques -- Code of practice for information security management  ...more information
ISO/IEC 20000-1:2011 Information technology –Service management –Part 1: Specification  ... more information
ISO/IEC 15288:2008-Systems and software engineering-System life cycle processes  ... more information
Guide to Software Engineering Standards and Specifications -Part I
Software Development and Maintenance Standards ... more information
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) ... more information
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) ... more information





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