[Company Name]

[Company Group, Division, Location]

Document Title: Design History File

Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Design History File
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

1.0 Purpose..........................................................................................................................................................3

2.0 Scope.............................................................................................................................................................3

3.0 DEFINITIONS..............................................................................................................................................3
3.1 Design History File (DHF).................................................................................................................3
3.2 Design Input.......................................................................................................................................3
3.3 Design Output....................................................................................................................................3
3.4 Design Validation...............................................................................................................................3
3.5 Device Master Record (DMR)...........................................................................................................3
3.6 Product...............................................................................................................................................3
3.7 Product Development.........................................................................................................................3
3.8 Quality System...................................................................................................................................3
3.9 Validation...........................................................................................................................................3
3.10 Verification.........................................................................................................................................3

4.0 Responsibilities and Requirements...............................................................................................................4

4.1 Product Manager................................................................................................................................4
4.2 Regulatory Affairs/Quality Systems Director....................................................................................4

5.0 References.....................................................................................................................................................4

6.0 Procedure......................................................................................................................................................4
6.1 Purpose of Design History File..........................................................................................................4
6.2 Location of Design History File.........................................................................................................4
6.3 Contents of Design History File.........................................................................................................5
6.3.1 Product Development Documents.......................................................................................5
6.3.2 Technical Report Documents...............................................................................................5
6.4 Maintenance of Design History File..................................................................................................5

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[Company Name] Design History File
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
This procedure defines the Design History File for containing or referencing the records necessary to
demonstrate product development in accordance with the approved design plan and design input
requirements.

2.0 Scope
This procedure applies to all product development programs funded and managed by [Company Name].

3.0 DEFINITIONS

3.1 Design History File (DHF)

A compilation of records, which describes the design history of a finished product.

3.2 Design Input

The physical and performance requirements of a product used as a basis for product design and
development.

3.3 Design Output

The results of a design effort at each design phase and at the end of the total design effort. The
finished design output is the basis for the Device Master Record. The total finished design output
consists of the product, its packaging and labeling, and the Device Master Record.

3.4 Design Validation

Establishing by objective evidence that product specifications conform to user needs and intended
use(s).

3.5 Device Master Record (DMR)

A compilation of records containing the procedures and specifications for a finished product.

3.6 Product
Unless otherwise specified, the word "product" in this procedure is used in the more global sense
to refer to components, materials, structures, machines, devices, systems, processes, software, or
services.

3.7 Product Development

The systematic product development process for optimizing time to market, cost, product
performance, customer satisfaction, and risk management, by simultaneously integrating all
product knowledge and expertise from concept, through manufacturing and customer
satisfaction, to the end of the product's life.

3.8 Quality System

The organizational structure, responsibilities, procedures, processes, and resources for
implementing quality management.

3.9 Validation
Confirmation by examination and provision of objective evidence that the particular requirements
for a specific intended use can be consistently fulfilled.

3.10 Verification
Confirmation by examination and provision of objective evidence that specified requirements
have been fulfilled.

4.0 Responsibilities and Requirements

This procedure is intended as a guide. Depending on the complexity of the product and the extent of
the design requirements, the Product Manager and the Executive Management Team may not exactly

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[Company Name] Design History File
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

follow this procedure, but must still meet the essential requirements for establishing and maintaining
design history.

4.1 Product Manager

The Product Manager bears overall responsibility for successful management of the development
program and establishing and maintaining the Design History File.

4.2 Regulatory Affairs/Quality Systems Director

The Director of Regulatory Affairs/Quality Systems is responsible for assuring the quality of the
product design process, the manufacturing process, the product, and all phases of the Product
Development Cycle. The Director of Regulatory Affairs/Quality Systems is responsible for
maintaining required hard copies of Design History File documents and design history archives
of completed product development programs.

5.0 References
“Design Control Guidance for Medical Device Manufacturers”, FDA Center for Devices and
Radiological Health, March 11, 1997
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Kimberly
Trautman, ASQ Quality Press
The Product Development Cycle
Development of Design Output

6.0 Procedure

6.1 Purpose of Design History File

The basic purpose of the Design History File is maintenance of the records that demonstrate
development of the product in accordance with the Product Development. Plan (the design plan)
and the Marketing Requirements Document (the product design input requirements). Beyond
satisfying this regulatory requirement, the Design History File provides other benefits. It
contains the information necessary to validate a product design in a known location where it can
be maintained throughout the life cycle of the product. It is also a storage base of the technical
knowledge supporting the product design. Developers can access the Design History File to
develop future models of this product or entirely new products using similar technology.

6.2 Location of Design History File

It is usually not possible to maintain all of the design history documentation for a product design
in a single location. Typically, developers maintain design history documentation in many
places. Design history may include entries in laboratory notebooks, internal memoranda,
electronic mail, and other documents stored at various physical locations. However, the Design
History File must contain or reference all essential documents verifying development of the
product in accordance with design control requirements.

[Company Name] maintains electronic design history files in a secure directory on the internal
company network. Document Control maintains required hard copies of design history
documents in a secure location separate from Device Master Record documentation. Hard copies
include documents requiring signature approval and documents managed under production
document change control procedures. Document Control maintains completed laboratory
notebooks in a secure location in accordance with Laboratory Notebook Procedures.

6.3 Contents of Design History File

6.3.1 Product Development Documents

The following are examples of possible types of design history. See Development of
Design Output for further descriptions of design history documentation.

 Authorization to Continue Development

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[Company Name] Design History File
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

 Marketing Requirements Document

 Development Report
 Design Review Documentation
 Manufacturability Report
 Meeting Agendas and Minutes
 Product Development Plan
 Master Schedule
 Release to Full Production and Support
 Test Plans (Reliability, Verification, Validation, etc.)

6.3.2 Technical Report Documents

The following are examples of possible types of technical reports. See Development of
Design Output, for further descriptions of technical reports.

 Design Validation Reports

 Design Verification Reports
 Error Budget Reports
 Product Support Reports
 Reliability Test Reports
 Risk Analysis Reports
 Sensitivity Analysis Reports

6.4 Maintenance of Design History File

The Product Manager is responsible for maintaining the Design History File. The Business
Management Team, Product Development Team, Product Development Task Teams, and other
developers provide the Product Manager with all design history documentation for filing or
referencing in the Design History File.

After completing the product Release to Production and the conclusion of a development
program, the Product Manager turns over the design history documentation for that product and
program to the Quality Systems Manager. Document Control files the product design history
documentation in the design history archives along with any original hard copies of design
history. From this point, the product accumulates design history as part of the change control
system. A new product model generates a new program.

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