IEC 62304 Templates

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Document Template
Dr. Oliver Eidel

SOP Integrated Software Development

Dr. Oliver Eidel
updated 6 months ago
Document Template
Dr. Oliver Eidel

Software Development and Maintenance Plan

Dr. Oliver Eidel
updated 9 months ago
Document Template
Dr. Oliver Eidel

SOUP List (Software of Unknown Provenance)

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Sven Piechottka

User Needs List

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Checklist: User Needs Review

Sven Piechottka
updated about 1 year ago
Document Template
Dr. Oliver Eidel

Software Requirements List

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

Software System Test Plan

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

IEC 62304:2006 Mapping of Requirements to Documents

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

SOP Software Problem Resolution

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

SOP Change Management

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

Checklist: Software Requirements Review

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Dr. Oliver Eidel

Checklist: Software Release

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Sven Piechottka

Bug Fixes Documentation List

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Change Evaluation List

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

List of Known Anomalies

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Machine Learning Algorithm Validation Report

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

List of Medical Devices

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

SOP Deployment

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Software Architecture Description

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Software Architecture Checklist

Sven Piechottka
updated about 1 year ago