What is in a device history file?

The DHR serves as a production record for medical devices that you manufacture – entries into this document include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.

What is DHF and DMR?

In simple terms, a DHF (Design History File) marks the start of a particular device and documents how an OEM arrived at the final design. A DMR (Device Master Record) details the specific material, equipment, and environment requirements for production.

What goes into a DHF?

Here are the specific documents that you should include in your DHF:

User needs and design inputs you defined at the start of the project.
Design outputs that you generated to build the device.
Design verification and validation protocols and reports.

What is DMR and DHR?

DHR – Device History Record Date(s) of manufacture. Quantity manufactured. Quantity released. Acceptance records demonstrating compliance with the DMR. Primary identification label and labelling for each unit.

What is the purpose of design history file?

Design History File (DHF) – compilation of records which describes the design history of a finished device.

Why is a design history file important?

The DHF is a compilation of documents that describe the design and development activities of a medical device. Its purpose is to show that the medical device was developed using the design control process, pictured below, needed to meet FDA requirements.

What is DHF index?

A Design History File Index is a summary of the deliverables (most often documents) that makes up the Design History File. It includes information such as the title, version, and location of each deliverable. The deliverables of the DHF (e.g. Product Requirement Document, Master Test Plan, Risk Management Plan).

What is device master file?

A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.

What is an FDA Master File?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

What is a DMR FDA?

A DEVICE MASTER RECORD (DMR) CONTAINS ALL OF THE INFORMATION AND SPECIFICATIONS NEEDED TO PRODUCE A MEDICAL DEVICE FROM START TO FINISH, INCLUDING INSTRUCTIONS FOR ALL MANUFACTURING PROCESSES, DRAWINGS, DOCUMENTED SPECIFICATIONS AND LABELING AND PACKAGING REQUIREMENTS.

What is a device master file?