Design History File:

Product Name:

Company Name:

Company Address:

Version No:

Date......................................

Revision History
Version Number Date

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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............................................................................................................................. 4
3.10 Verification........................................................................................................................... 4

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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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)

Provide a compilation of records, drawings and descriptions which describes the design
history of the finished product.

3.2 Design Input

Describe 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 labelling, and the Device
Master Record.

3.4 Design Validation

This includes objective evidence that the product conforms with product specification to
user’s needs and intended use(s). Details of ethnographics review to be included.

3.5 Device Master Record (DMR)

A compilation of records containing:
 the procedures
 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

Outline the organisational structure, responsibilities, procedures, processes, and
resources for implementing the quality management system. ISO13485

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

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 (appointee) and the Executive
Management Team must meet the essential requirements for establishing and maintaining the
design history.

4.1 Product Manager

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

4.2 Regulatory Affairs/Quality Systems Personnel

The Regulatory Affairs/Quality Systems (appointee) 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 Regulatory Affairs/Quality Systems (appointee) is responsible for maintaining

required hard copies of Design History File documents and design history archives of
completed product development programs.

5.0 References

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

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.

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 [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

 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 (or designee) is responsible for maintaining the Design History File.
The Team – engineers, Product Development Team, and other developers (include all
relevant personnel) provide the Product Manager (or designee) 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 (or designee) releases the design history documentation
for that product and program to the Quality Systems Manager. Document Control files
include 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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