Medical Device File (MDF) Template – QMSR Compatible

QMSR Compatible Medical Device File (MDF) Template

The Medical Device File is the central repository for all technical documentation related to your device. This template provides a structured MDF framework compatible with QMSR (21 CFR Part 820) and ISO 13485:2016, ensuring your device documentation is complete, organized, and inspection-ready.

What's Included

• Complete Medical Device File structure and index template compatible with QMSR
• Device description and intended use documentation guidance
• Design, manufacturing, and post-market documentation requirements
• MDF maintenance and update procedures
• Editable in Microsoft Word and Google Docs

Instant digital download. No shipping required.