Scribd
Upload
78 views3 pages

Device Master File Medical Device Template

The document outlines a Device Master File (DMF) template for medical devices, detailing essential sections such as device description, labeling information, design and manufacturing details, risk management, and clinical evidence. It includes requirements for verification and validation, sterilization information, software documentation, packaging, post-market surveillance, and regulatory information. This comprehensive template ensures compliance with relevant standards and regulations for medical device approval.

Uploaded by

vignesh10248
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
78 views3 pages

Device Master File Medical Device Template

The document outlines a Device Master File (DMF) template for medical devices, detailing essential sections such as device description, labeling information, design and manufacturing details, risk management, and clinical evidence. It includes requirements for verification and validation, sterilization information, software documentation, packaging, post-market surveillance, and regulatory information. This comprehensive template ensures compliance with relevant standards and regulations for medical device approval.

Uploaded by

vignesh10248
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

DEVICE MASTER FILE (DMF) TEMPLATE FOR

MEDICAL DEVICES

1. Device Description and Product Specification

• Device name, model, and variants


• Intended use / purpose
• Indications for use
• Principle of operation
• Device classification as per MDR 2017
• List of accessories and components
• Product specifications and performance characteristics

2. Labeling Information

• Primary label artwork


• Secondary label artwork
• IFU (Instructions for Use)
• Symbols used as per ISO 15223-1
• Packaging details

3. Design and Manufacturing Information

• Design drawings and diagrams


• Bill of materials (BOM)
• Manufacturing process flow chart
• Work instructions and SOP references
• Environmental controls

4. Risk Management

• Risk Management Plan (ISO 14971)


• Risk analysis and evaluation
• Risk control measures
• Residual risk analysis
• Risk management report
5. Essential Principles Checklist

• Checklist demonstrating conformity to essential principles of safety and performance

6. Verification and Validation

• Design verification reports


• Design validation reports
• Software validation (if applicable)
• Biocompatibility testing
• Electrical safety testing
• Performance evaluation

7. Sterilization Information (if applicable)

• Sterilization method
• Validation report
• Sterility assurance level
• Packaging validation

8. Clinical Evidence

• Clinical evaluation report


• Literature review
• Clinical investigation data (if applicable)

9. Software Documentation (if applicable)

• Software architecture
• Source code control
• Software risk analysis
• Cybersecurity considerations

10. Packaging and Shelf Life


• Packaging validation report
• Transportation validation
• Shelf life study report

11. Post Market Surveillance

• PMS plan
• Vigilance reporting procedure
• Complaint handling procedure

12. Regulatory Information

• Manufacturing license
• Test license (if applicable)
• Standards followed (ISO 13485, ISO 14971, IEC 60601, etc.)
• Declaration of conformity

You might also like