The document discusses requirements for maintaining a Design History File (DHF) for medical devices. A DHF is a compilation of records that describes the design history of a finished medical product. It must contain or reference records demonstrating that the design was developed according to the approved design plan and regulatory requirements. The DHF includes documents such as design plans, specifications, validation data, and draft regulatory documents to show that requirements were met. Procedures outline general maintenance of the DHF, including storage, version control, and ensuring confidentiality throughout the design process.

1. Quality Management
Documents & Templates
Design History File (DHF)
A documented, comprehensive, systematic examination of a design
to evaluate the adequacy of the design requirements, to evaluate the
Design Review
capability of the design to meet those requirements, and to identify
problems.
A compilation of Records that describes the design history of a
Design History File
Finished Product.
A representative group designated at the initiation of Design Control
Design Review Committee consisting of all functions supporting the design, development, and
manufacturing of a Product.
Medical Device Medical device, components and finished medical device.
A systematic use of available information to identify Hazards and to
Risk Analysis
estimate the Risk.
7 PROCEDURE
The Quality System Regulation (QSR) requires that the DHF shall contain or reference the records
necessary to demonstrate that the design was developed in accordance with the approved design
plan and the requirements of this part. This requirement will be met by maintaining plans that meet
the design control requirements. The plans and subsequent updates must be part of the DHF. The
results of the design verification, including identification of the design, method(s), the date, and the
individual(s) performing the verification, must be documented in the DHF. The DHF contains
documents such as the design plans and input requirements, preliminary input specs, validation
data and preliminary versions of key DMR documents. These are needed to show that plans were
created, followed and specifications were met.
7.1 General Maintenance of Design History File
The DHF must be maintained for each medical devices project once the COMPANY decided to
develop under Design Control or as required by 21 CFR Part 820, Quality System Regulation.
Project Leader/ Head of Engineering maintains the DHF file while the during the whole design
project including successful transfer where applicable and ensures confidentiality of the file and
must enter the title of each document that is put into the DHF into the Design History File Table
of Contents.
All design documentation is stored and organized in a manner to facilitate full traceability and
document retrieval and prevent the inadvertent loss of records.
7.2 Content of the DHF
Document Type Document ID Version Status Page
SOP XX_WWW_ZZZ_YYYY 1.0 Approved 6/9
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