Medical Device File Folder Structure
Medical Device File Folder Structure
Template Overview
Template Overview
Ensure your medical device Technical Documentation is structured for EU MDR 2017/745, IVDR 2017/746, and global regulatory compliance with our pre-organized Technical File Folder Structure. Designed for manufacturers, regulatory teams, and consultants, this ready-to-use folder system simplifies documentation management, ensuring a clear, logical, and audit-ready structure.
Key Features
Key Features
✔ Pre-Organized Folder Hierarchy – Based on Annex II & III MDR/IVDR requirements.
✔ Dedicated Sections for Key Documentation:
✔Device Description & Intended Use
✔General Safety & Performance Requirements (GSPR) Checklist
✔Risk Management (ISO 14971 Compliance)
✔Clinical/Performance Evaluation Reports
✔Manufacturing & Quality System Documentation (ISO 13485)
✔Post-Market Surveillance & Vigilance
✔ Customizable & Ready-to-Use – Easily adapt for different device classifications and regulatory frameworks.
✔ Supports Global Submissions – Compatible with UKCA, and CE Marking requirements.
Why choose a QMS Template?
Why choose a QMS Template?
This downloadable folder structure eliminates confusion, saves time, and ensures your documentation is logically organized and regulatory-ready for audits or submissions.
Download the Medical Device Technical File Folder Structure today and take the stress out of regulatory compliance!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.