Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulator

Design History File (DHF), Device Master Record (DMR)

, Device History Record (DHR) and Technical File (TF) - Regulator

Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).

Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? Attend this Webinar to have these questions answered.

Why should you attend: Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?

Areas Covered in the Session:

FDA Quality Systems Regulation Requirements/Definitions

MDD Requirements/Definitions

Design History File (DHF) Definition

Typical contents

DHF and outsourced design/production

DHF and OEM relationships

Device Master Record (DMR) Definition

Typical contents

DMR and outsourced design/production

DMR and OEM relationships

Controlling and maintaining DMR

Device History Record (DHR) Definition

Contents

UsingDHR datafor tracking and trending

DHR and outsourceddesign/production

DHRand OEM relationships

Technical File (TF) Definition

Contents

TF and outsourceddesign/production

TFand OEM relationship

Design/process changes and DHF, DMR, DHR, and TF

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