[Company Name]

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Document Title: Design Verification

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COMPANY PROPRIETARY AND CONFIDENTIAL

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

Table of Contents

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 Review....................................................................................................................................2
3.5 Design Validation...............................................................................................................................2
3.6 Device Master Record (DMR)...........................................................................................................2
3.7 Process Validation..............................................................................................................................2
3.8 Product...............................................................................................................................................2
3.9 Product Development.........................................................................................................................2
3.10 Quality................................................................................................................................................2
3.11 Quality System...................................................................................................................................3
3.12 Specification.......................................................................................................................................3
3.13 Validation...........................................................................................................................................3
3.14 Verification.........................................................................................................................................3
3.15 Verification Test Plan.........................................................................................................................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
4.4 Task Teams.........................................................................................................................................3
4.5 Product Development Team (PDT)....................................................................................................3

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

6.0 Procedure......................................................................................................................................................4
6.1 Purpose of Design Verification..........................................................................................................4
6.2 Verification Techniques......................................................................................................................4
6.3 Planning for Design Verification.......................................................................................................4
6.4 Conducting Design Verification.........................................................................................................5
6.5 Documenting Design Verification Activities.....................................................................................5
6.6 Review of Design Verification...........................................................................................................5

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

1.0 Purpose
This procedure defines the process for conducting and documenting design verification during the
development of a product design.

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 Review

A documented, comprehensive, systematic examination of a design to evaluate the adequacy of
the design requirements, to evaluate the capability of the design to meet the requirements, and to
identify problems.

3.5 Design Validation

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

3.6 Device Master Record (DMR)

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

3.7 Process Validation

Establishing by objective evidence that a process consistently produces a result or product
meeting its predetermined specifications.

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 Product Development

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

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

3.11 Quality System

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

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

3.12 Specification
Any requirement to which a product must conform.

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

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

3.15 Verification Test Plan

The written procedures and protocol to conduct verification testing of a prototype, subsystem, or
component to verify that the design output meets the design input requirements and confirm
compliance with the Marketing Requirements Document.

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, the Executive Management Team, and the Product
Development Team may not exactly follow this procedure, but must still apply the essential elements of
effective and systematic design verification.

4.1 Executive Management Team (EMT)

The Executive Management Team has comprehensive responsibility and authority to plan, direct,
and manage the business and strategic objectives of product development programs.

4.2 Product Manager

The Product Manager bears overall responsibility for successful management of the development
program and is responsible for leading and facilitating the efforts of the Product Development
Team. As the leader of the Product Development Team, the Product Manager is responsible for
coordinating and integrating their activities and acting as liaison with the Business Management
Team.

4.3 Regulatory Affairs/Quality Systems Director

The Director of Regulatory Affairs/Quality Systems Director 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 Quality Systems Manager is responsible for assuring the
verification of the product design to all its design input requirements and design specifications.

4.4 Task Teams

Task Teams have responsibility and authority to plan and execute Sub-Plans and other Product
Development Tasks assigned by the Product Development Team.

4.5 Product Development Team (PDT)

The Product Development Team has collective responsibility and authority to plan, direct, and
manage the activities and deliverables of a development program and to carry out the objectives
of the Business Management Team. It is responsible for advising, coordinating, and integrating
the activities of the Task Teams.

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

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

6.0 Procedure
Design verification activities are an essential element to assuring the quality of a product during the
stages of design development. As development progresses, these activities must become increasingly
more comprehensive to account for the interactions between components, subsystems, environment, etc.

6.1 Purpose of Design Verification

Task teams and individuals conduct verification tasks at all stages and levels of product design.
The nature of design verification varies according to the type of design output but always has the
essential purpose of confirming that design output meets the design input as detailed in the
Marketing Requirements Document, product specifications, etc. Varieties of techniques are
possible.

6.2 Verification Techniques

Task teams and individuals may employ a variety of techniques in the verification process
dependent on the design output to be verified. Verification techniques typically fall into three
basic categories of tests, inspections, and analysis. Consider any technique-establishing
conformance with a design input requirement as an acceptable means of verifying the design with
respect to that requirement. Select and apply appropriate verification techniques based on the
generally accepted practices for the technologies applied in the product. Since many of these
techniques are an integral part of design development, they will be performed routinely in the
development process. However, be vigilant in making verification tasks explicit, measuring the
thoroughness of their execution, and documenting the results in detail. The following are some
examples of verification techniques.

 Risk Analysis (Failure Mode Effects Analysis, Fault Tree Analysis, etc.)
 Materials compatibility
 Biocompatibility
 Thermal analysis
 Environmental functional tests
 Electronic functional tests
 Package integrity tests
 Stress analysis
 Comparison of design to a previous proven product design

When using comparison with a proven design or alternative calculation methods, review their
appropriateness in relation to the new application as part of the design verification process.
When using a standard as the source of a verification procedure, specify the standard and ensure
it is applicable.

Do not equate production testing with verification. Verification testing establishes conformance
of design output with design input. Production testing establishes proper manufacturing of the
product and is rarely, if ever, comprehensive enough to verify the design.

6.3 Planning for Design Verification

During the Planning Phase of the Product Development Cycle, the Product Manager and the
Product Development Team integrate verification tasks into the Product Development Plan. As
much as possible, planning encompasses requirements for component level verifications through
system level verifications of both engineering and manufacturing prototypes. The Product
Manager and Product Development Team review the planning of verification tasks for accuracy
and ensure that all activities are traceable to design specifications. Furthermore, using tools such
as a traceability matrix or verification checklist, ensure planned verification tasks exist for all
design input requirements and design specifications.

As the design development proceeds, revise and update the Product Development Plan. At the
end of each development phase, review the verification tasks and make changes if necessary prior
to beginning the next phase. Ensure that verification completed at an earlier stage remains valid
or is repeated on the design in a later stage.

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

6.4 Conducting Design Verification

The Product Development Team is responsible for the conduct of design verification in every part
of the design process at all stages and levels of product design. As previously stated, verification
consists of tests, inspections, analysis, or any other technique establishing conformance with a
design input requirement. Verification should be as independent as practical from the original
design process including independent calculation methods, different equipment, and personnel
other than those responsible for the design under evaluation. Prior to conducting the verification
task, establish the evaluation criteria, the method of verification, and a detailed verification
procedure in a test plan. The plan is the protocol for conducting verification testing of a
prototype, subsystem, or component to specifically verify that the design output meets the design
input requirements and confirm compliance with the Marketing Requirements Document.
Normally, the verification test plan is formally documented in the technical report after
completion of the verification task. For other, more complex verification tasks (or when
specified), prepare a formal Verification Test Plan prior to performing the verification task.

6.5 Documenting Design Verification Activities

Immediately upon completion of a verification task, complete a Technical Report for Design
Verification. Include an identification of the design under evaluation, the verification method
and procedure, the date, and the individuals performing the verification. Record results, analysis,
interpretations, and the operating conditions during verification. Remember that evaluation of
the results is as important as the process itself. The Product Manager will add the technical
report and the Verification Test Plan (if applicable) to the Design History File along with the
results of all other verification activities and tasks.

Design verification is the compilation of the results of all verification activities and may include
many Technical Reports for Design Verification. The Product Manager tracks completion of
verification tasks with a verification checklist and reviews verification results in formal reviews
of that design.

6.6 Review of Design Verification

Formal design reviews are an important part of design verification. The primary purpose of
Technical Design Reviews is design verification. Reviewers will review verification results along
with the other design output. During the review process, reviewers determine the adequacy of
verification activities while considering factors such as conflicting design requirements,
unforeseen constraints, etc. Reviewers also confirm traceability of verification tasks to the design
input requirements (detailed in the Marketing Requirements Document) and design
specifications. To improve traceability, the Product Manager prepares a verification checklist
showing each product design input requirement or specification and the corresponding document
demonstrating verification. Verification may expose deficiencies in the original design input
requirements or design specifications. The reviewers resolve deficiencies with corrective action if
the deficiency is not judged insignificant or erroneous.

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