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Software Engineering
guides, templates, checklists for software development
compliance with software engineering standards
 

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, 
ISO/IEC 20000, ANSI/AAMI/ISO 13485, ISO 9001, ISO/IEC 90003

guides - templates - checklists

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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 12207:2008
Evidence Product Checklist for the standard ISO/IEC 12207:2008 Software Life Cycle Processes
ISO/IEC 15288:2008
Evidence Product Checklist for the standard ISO/IEC 15288-System Engineering-System Life Cycle Processes 
ISO 9001:2008
Evidence Product Checklist for the standard ISO 9001:2008 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 
ANSI/AAMI/ISO 13485:2003
Evidence Product Checklist for
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes
ISO/IEC 20000-1:2005
Evidence Product Checklist for  Information Technology - Service Management - Part1: Specification
The standard ISO/IEC 20000-1:2005 promotes .......
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)
Set of Templates for Software Configuration Management Documents - Version 5.0. Compliance with IEC 62304, ISO/IEC 15288, ISO/IEC 12207 
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 12207:2008 
Evidence Product Checklist for the standard ISO/IEC 12207:2008 Software Life Cycle Processes
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 9001:2008 
Evidence Product Checklist for the standard ISO 9001:2008 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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