[Company Name]

[Company Group, Division, Location]

Document Title: Design Transfer

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COMPANY PROPRIETARY AND CONFIDENTIAL

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

Table of Contents

Table of Contents...................................................................................................................................................1

1.0 Purpose..............................................................................................................................................................2

2.0 Scope.................................................................................................................................................................2

3.0 Definitions.........................................................................................................................................................2
3.1 Design History File (DHF).....................................................................................................................2
3.2 Design Input............................................................................................................................................2
3.3 Design Output.........................................................................................................................................2
3.4 Design Validation...................................................................................................................................2
3.5 Device Master Record (DMR)...............................................................................................................2
3.6 Final Product Development Review......................................................................................................2
3.7 Pilot Production......................................................................................................................................2
3.8 Product....................................................................................................................................................2
3.9 Production Specifications.......................................................................................................................2
3.10 Product Development...........................................................................................................................2
3.11 Quality..................................................................................................................................................3
3.12 Quality System.....................................................................................................................................3
3.13 Specification.........................................................................................................................................3
3.14 Validation.............................................................................................................................................3
3.15 Verification...........................................................................................................................................3

4.0 Responsibilities and Requirements...................................................................................................................3

4.1 Executive Management Team (EMT)...................................................................................................3
4.2 Product Manager.....................................................................................................................................3
4.3 Regulatory Affairs/Quality Systems Director........................................................................................3

5.0 References.........................................................................................................................................................3

6.0 Procedure...........................................................................................................................................................3
6.1 Objective of Design Transfer.................................................................................................................3
6.2 Number of Final Product Development Reviews..................................................................................4
6.3 Conducting Final Product Development Reviews.................................................................................4
6.4 Documenting Design Transfer...............................................................................................................4

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

1.0 Purpose
This procedure defines the process for ensuring that the product design is correctly translated into
Production Specifications and properly transferred to Manufacturing.

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 Final Product Development Review

The Product Development Review(s) conducted by the Product Manager at the end of the Pilot
Production Phase to verify attainment of objectives for the development program, to ensure the
product is correctly translated into Production Specifications, and to transfer the product design
to Full Production and Support.

3.7 Pilot Production

Initial trial production run(s) made under full-scale production conditions after installation of the
complete manufacturing process.

3.8 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.

3.9 Production Specifications

A compilation of documents such as assembly drawings, component specifications,
manufacturing instructions, test specifications, workmanship standards, etc., or any other equally
acceptable means, written and unwritten, to communicate and convey design information to
Manufacturing for the purpose of repeatedly and reliably manufacturing a product.

3.10 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.

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

3.11 Quality
The totality of features and characteristics that bears on the ability of a product to satisfy fitness-
for-use, including safety and performance.

3.12 Quality System

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

3.13 Specification
Any requirement to which a product must conform.

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

3.15 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
follow this procedure, but must still apply the essential elements of effective and systematic design
transfer.

4.1 Executive Management Team (EMT)

The Executive Management Team has comprehensive responsibility and authority to plan,
direct, and manage all activities and deliverables of a development program and to carry out the
strategic objectives of Executive Management.

4.2 Product Manager

The Product Manager bears overall responsibility for management of the development program
and is responsible for leading and facilitating the efforts of the Product Development Team. In
addition to planning, scheduling, and documenting the Final Product Development Review, the
Product Manager determines the type and scope of the review, selects the individual reviewers,
and conducts the review. The Product Manager assures proper execution of design transfer
throughout the development cycle.

4.3 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.

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
Design Review

6.0 Procedure

6.1 Objective of Design Transfer

Design Transfer is the process of transferring product design information (Production
Specifications) to Manufacturing for the purposes of manufacturing the product. This transfer

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

does not occur at a single time but takes place throughout the design process in the form of
documentation, training, and possibly personnel. However, Design Transfer is formalized in one
or more Final Product Development Reviews following completion of all verification and
validation activities and a pilot production run to determine the adequacy of full-scale
manufacturing.

The essential objective of Design Transfer is to ensure that the product can be repeatedly and
reliably manufactured within product and process capabilities using the Production
Specifications as transferred to Manufacturing. Although Design Transfer occurs throughout the
design development process, reviewers must address the following elements at the Final Product
Development Review.

• Accomplish a qualitative assessment of the completeness and adequacy of the Production

Specifications.
• Verify the proper verification and validation of all design input requirements.
• Verify the approval of all Production Specifications.
• Verify the Production Release of all Production Specifications.
• Verify the completion of all statutory and regulatory approval requirements.
• Verify attainment of the development program's objectives.

6.2 Number of Final Product Development Reviews

The number of Final Product Development Reviews may vary depending on the complexity of
the product and the extent of the design requirements. The Product Manager must exercise care
to limit the scope of an individual review to something reasonably manageable within the
allocated time. Reviews that are overly long become self-defeating.

6.3 Conducting Final Product Development Reviews

The Product Manager plans, schedules, conducts, and documents each Final Product
Development Review. The Product Manager selects reviewers, prepares for the review,
conducts the review, and implements corrective actions in accordance with the Design Review
procedure.

6.4 Documenting Design Transfer

The Product Manager prepares minutes for each Final Product Development Review detailing
the topics, the date, the reviewers, a synopsis of the discussion and conclusions, and the
identified problems with their corresponding disposition. The reviewers approve the minutes
and the Product Manager documents the minutes in the Design History File.

The Product Manager also prepares a Release to Full Production and Support approved by the
Executive Management Team and documented in the Design History File.

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