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Software
Engineering
guides,
templates, checklists for software development
and
for the application of software engineering standards to computer software |
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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
IEEE/EIA 12207.0, ANSI/AAMI/ISO 13485
ISO 9001, ISO/IEC 90003
guides - templates -
checklists |
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| Checklists
for the application of software engineering standards |
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ISO/IEC
27002:2005
Evidence Product Checklist
for the standard
Information Technology - Security Techniques -
Code of practice for information security management
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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
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FDA
21 CFR
Evidence Product Checklist
for the FDA Document “FDA 21 CFR Part 11 Electronic Records; Electronic
Signatures; Final Rule”
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IEC 62304:2006
Evidence Product Checklist
for the standard IEC 62304:2006 - Medical Device Software- Software Life
Cycle Processes
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ISO/IEC
12207
Evidence Product Checklist
for the standard ISO/IEC 12207 Software Life Cycle Processes, including
Amendment 1 and Amendment 2
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ISO/IEC
15288
Evidence Product Checklist
for the standard ISO/IEC 15288-System Engineering-System Life Cycle Processes
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ISO
9001:2000
Evidence Product Checklist
for the standard ISO 9001:2000 Quality Management – Requirements
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ANSI/UL
1998
Evidence Product Checklist
for the standard ANSI/UL 1998 for Software in Programmable Components
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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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ISO/IEC
90003:2004
Supplier Assessment Checklist
for the evaluation of software regarding compliance with the standard ISO/IEC 90003:2004
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IEEE/EIA
12207.0-1996
Evidence Product Checklist
-IEEE/EIA 12207.0-1996 Industry Implementation of the International Standard
ISO/IEC: 12207 Software Life Cycle Processes
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ANSI/AAMI/ISO
13485:2003
Evidence Product Checklist
for
ANSI/AAMI/ISO 13485:2003
Medical devices - Quality management systems- Requirements for regulatory
purposes
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Evidence
Product Checklist for the FDA Document “General Principles of Software
Validation” Final Guidance for Industry and FDA staff’
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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”
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Evidence
Product Checklist for the FDA Document “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices”
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| Guides
to software engineering standards, templates for documentation development,
etc. |
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Guide
to Software Engineering Standards and Specifications -Part I
Software Development and
Maintenance Standards
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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)
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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)
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Template
for Software Configuration Management Documents - Standard Version
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Templates
for Software Configuration Management Documents - Deluxe Version 3.0
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Template
for a Software Maintenance Plan
(ISO/IEC
12207, ISO/IEC 14764)
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Template
for a Software Documentation Management Plan
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Template
for a System Documentation Management Plan
Includes ISO/IEC 15288,
System Life Cycle Processes (2002), Section 5.4.8
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Checklists
for Medical Device Firms
for the application of
related standards |
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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
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IEC 62304:2006
Evidence Product Checklist
for the standard IEC 62304:2006 - Medical Device Software- Software Life
Cycle Processes
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ISO/IEC
12207
Evidence Product Checklist
for the standard ISO/IEC 12207 Software Life Cycle Processes, including
Amendment 1 and Amendment 2
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ANSI/UL
1998
Evidence Product Checklist
for the standard ANSI/UL 1998 for Software in Programmable Components
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Evidence
Product Checklist for the FDA Document “General Principles of Software
Validation” Final Guidance for Industry and FDA staff’ - Release date January
11, 2002
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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”
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Evidence
Product Checklist for the FDA Document “Guidance for the Content of
Pre-market Submissions for Software Contained in Medical Devices”
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Evidence
Product Checklist for
ANSI/AAMI/ISO 13485:2003
Medical devices - Quality management systems- Requirements for regulatory
purposes
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ISO
9001:2000
Evidence Product Checklist
for the standard ISO 9001:2000 Quality Management – Requirements
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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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