IEC 62304 Templates
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Document Template

SOP Integrated Software Development
Dr. Oliver Eidel
updated 6 months ago
Document Template

Software Development and Maintenance Plan
Dr. Oliver Eidel
updated 9 months ago
Document Template

SOUP List (Software of Unknown Provenance)
Dr. Oliver Eidel
updated about 1 year ago
Document Template

User Needs List
Sven Piechottka
updated about 1 year ago
Document Template

Checklist: User Needs Review
Sven Piechottka
updated about 1 year ago
Document Template

Software Requirements List
Dr. Oliver Eidel
updated about 1 year ago
Document Template

Software System Test Plan
Dr. Oliver Eidel
updated about 1 year ago
Document Template

IEC 62304:2006 Mapping of Requirements to Documents
Dr. Oliver Eidel
updated about 1 year ago
Document Template

SOP Software Problem Resolution
Dr. Oliver Eidel
updated about 1 year ago
Document Template

SOP Change Management
Dr. Oliver Eidel
updated about 1 year ago
Document Template

Checklist: Software Requirements Review
Dr. Oliver Eidel
updated about 1 year ago
Document Template

Checklist: Software Release
Dr. Oliver Eidel
updated about 1 year ago
Document Template

Bug Fixes Documentation List
Sven Piechottka
updated about 1 year ago
Document Template

Change Evaluation List
Sven Piechottka
updated about 1 year ago
Document Template

List of Known Anomalies
Sven Piechottka
updated about 1 year ago
Document Template

Machine Learning Algorithm Validation Report
Sven Piechottka
updated about 1 year ago
Document Template

List of Medical Devices
Sven Piechottka
updated about 1 year ago
Document Template

SOP Deployment
Sven Piechottka
updated about 1 year ago
Document Template

Software Architecture Description
Sven Piechottka
updated about 1 year ago
Document Template

Software Architecture Checklist
Sven Piechottka
updated about 1 year ago