Free EU MDR templates
Open-source, no-strings-attached templates for EU MDR compliance — ISO 13485, IEC 62304, ISO 14971 and IEC 62366. Download them as Word, PDF, Markdown or HTML.
General MDR Documents
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MDD Essential Requirements
Dr. Oliver Eidel
Checklist: MDR General Safety and Performance Requirements
Sven Piechottka
MDR Classification Document
Sven Piechottka
Instructions for Use (IfU)
Sven Piechottka
ISO 13485 Templates
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IEC 62304 Templates
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SOP Integrated Software Development
Dr. Oliver Eidel
Software Development and Maintenance Plan
Dr. Oliver Eidel
SOUP List (Software of Unknown Provenance)
Dr. Oliver Eidel
User Needs List
Sven Piechottka
IEC 62366 Templates
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IEC 62366-1:2015 Mapping of Requirements to Documents
Dr. Oliver Eidel
Usability Evaluation Plan
Dr. Oliver Eidel
Usability Evaluation Protocol
Dr. Oliver Eidel
Usability Evaluation Report
Dr. Oliver Eidel
ISO 14971 Templates
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Risk Management Report
Dr. Oliver Eidel
Risk Management Plan
Dr. Oliver Eidel
Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"
Dr. Oliver Eidel
ISO 14971:2019 Mapping of Requirements to Documents
Dr. Oliver Eidel
Clinical Evaluation Templates
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Clinical Evaluation Plan
Dr. Oliver Eidel
Literature Evaluation Table (MDR Clinical Evaluation)
Sebastian Skorka
Checklist: Clinical Evaluation Report
Sebastian Skorka
Clinical Evaluation Report
Dr. Oliver Eidel
IVDR Templates
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GDPR Templates
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Technical and Organizational Measures
Sven Piechottka
List of Data Processing Activities with Data Protection Impact Assessment (DPIA)
Sven Piechottka
Data Protection Statement (Privacy Policy)
Sven Piechottka
Employee Data Protection and Confidentiality Agreement
Sven Piechottka
ISO 27001 Templates
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SOP Information Security Risk Assessment
Dr. Oliver Eidel
Information Security Policy And Scope
Dr. Oliver Eidel
Information Security Controls
Dr. Oliver Eidel
ISO 27001:2023 Mapping of Requirements to Documents
Dr. Oliver Eidel
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