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How to Manage DMR/DHF/MDF
Getting Started
About Orcanos
About the Instructor
Definition
Known 483 on DMR, DHF and MDF Issues
Challenges
DMR/DHF/MDF Setup
The DMR, DHF & MDF Work Item
Medical Device File vs. Device Master Record
The contents of the Medical Device File according to ISO 13485
Medical Device File Procedure
Compliance Checklist for Technical Documentation
Device Master Record, Design History Record & Medical Device File
Adding/Changing/Deleting Data from Record
DMR/DHF/MDF Release Process
Export DMR, DHF & MDF
The contents of the Medical Device File according to ISO 13485
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