Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

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Areas Covered in the Session: FDA Quality Systems Regulation Requirements/Definitions
MDD Requirements/Definitions
Design History File (DHF)
Definition
Typical contents
Device Master Record (DMR)
Definition
Typical contents
Controlling and maintaining DMR
Device History Record (DHR)
Definition
Contents
Using DHR data for tracking and trending
Technical File (TF)
Definition
Contents
Design/process changes and DHF, DMR, DHR, and TF
Who Will Benefit: This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well. The employees who will benefit include:
Quality Managers/Engineers
Production/Process Managers/Engineers
Manufacturing Managers/Engineers
QA and QC managers, inspectors, supervisors and personnel
Documentation Specialists
Supplier Quality Managers/Engineers
Regulatory Managers/Engineers