[Company Name]

[Company Group, Division, Location] Document Title: Design Validation

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

CONTROLLED COPY/ MASTER COPY STAMP HERE

OTHER STAMP HERE

Revision Level DRAFT 1.00

Revision Date DD/MM/Y Y DD/MM/Y Y

DCO/ECO Number YY-00000 YY-00000

Description of Revision Draft Initial Release

Revision Author Author Name Author Name

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] [Company Group, Division, Location]

Design Validation [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 Customer.................................................................................................................................................2 3.2 Design History File (DHF).....................................................................................................................2 3.3 Design Input...........................................................................................................................................2 3.4 Design Output.........................................................................................................................................2 3.5 Design Review........................................................................................................................................2 3.6 Design Validation...................................................................................................................................2 3.7 Device Master Record (DMR)................................................................................................................2 3.8 Process Validation..................................................................................................................................2 3.9 Product....................................................................................................................................................2 3.10 Product Development...........................................................................................................................2 3.11 Quality...................................................................................................................................................2 3.12 Quality System......................................................................................................................................3 3.13 Specification.........................................................................................................................................3 3.14 Validation.............................................................................................................................................3 3.15 Validation Test Plan.............................................................................................................................3 3.16 Verification...........................................................................................................................................3 4.0 Responsibilities and Requirements...................................................................................................................3 4.1 Executive Management Team (EMT)....................................................................................................3 4.2 Product Manager.....................................................................................................................................3 4.3 Product Development Task Teams.........................................................................................................3 4.4 Product Development Team (PDT)........................................................................................................3 4.5 Regulatory Affairs/Quality Systems Director.........................................................................................3 5.0 References..........................................................................................................................................................4 6.0 Procedure...........................................................................................................................................................4 6.1 Purpose of Design Validation.................................................................................................................4 6.2 Validation Methods................................................................................................................................4 6.3 Planning for Design Validation.............................................................................................................4 6.4 Conducting Design Validation...............................................................................................................5 6.5 Documenting Design Validation Activities...........................................................................................5 6.6 Review of Design Validation..................................................................................................................5

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 1 of 6

[Company Name] [Company Group, Division, Location]

Design Validation [Document Number] Rev x.xx DD/MM/YY

1.0

Purpose This procedure defines the process for conducting and documenting design validation during the development of a product design. Scope This procedure applies to all product development programs funded and managed by [Company Name]. Definitions 3.1 3.2 3.3 Customer Anyone purchasing, using, operating, or interfacing with a product in any manner. Design History File (DHF) A compilation of records, which describes the design history of a finished product. Design Input The physical and performance requirements of a product used as a basis for product design and development. 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. 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. Design Validation Establishing by objective evidence that product specifications conform to user needs and intended use(s). Device Master Record (DMR) A compilation of records containing the procedures and specifications for a finished product. Process Validation Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. 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.

2.0 3.0

3.4

3.5

3.6

3.7 3.8

3.9

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

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 2 of 6

[Company Name] [Company Group, Division, Location]

Design Validation [Document Number] Rev x.xx DD/MM/YY

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 Validation Test Plan The written procedures and protocol to conduct field testing or clinical trials of a product for design validation. It establishes with objective evidence that product specifications conform with user needs and intended use(s) and confirms the validity of the design input requirements detailed in the Marketing Requirements Document in the customer's use environment. 3.16 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, 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 validation. 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. The EMT assures proper execution of design validation throughout the development cycle. 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. 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 Executive Management Team and Executive Management. Product Development Task Teams Product Development Task Teams have responsibility and authority to plan and execute SubPlans and other Product Development Tasks assigned by the Business Management Team. Task Teams are the primary executors of design validation activities. Product Development Team (PDT) The Product Development Team has collective responsibility and authority to plan, direct, and manage the technical activities and deliverables of the 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 Product Development Task Teams. The Product Development Team is responsible for the proper conduct of all design validation activities. 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

4.2

4.3

4.4

4.5

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 3 of 6

[Company Name] [Company Group, Division, Location]

Design Validation [Document Number] Rev x.xx DD/MM/YY

assuring the validation of the product design and that its specifications conform to user needs and intended use(s). 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 Procedure Design verification examines in detail all aspects of a product design at various development stages to confirm that design output meets design input. Design validation, however, conceptually is performed with respect to the design input requirements and answers the question did we design the correct product to meet user needs and intended use(s). 6.1 Purpose of Design Validation Task teams and individuals conduct validation tasks at appropriate stages of development on finished product under actual or simulated use conditions. Design validation goes beyond the technical aspects of design verification and assuring that design output meets design input. Validation, in essence, is the cumulative summation of all efforts establishing that the product design conforms to user needs and intended uses(s). In validating the product design, it is essential to consider expected variations in components, materials, manufacturing processes, and the use environment. Validation Methods Task teams and individuals may employ a number of methods to validate a product design. However, always conduct validation testing in the actual or simulated environment of use. Along with testing, apply other validation methods to confirm and support conclusions. The following are examples of other validation methods.

6.0

6.2

Analysis Inspection Safety assessment Compilation of relevant scientific literature Historical evidence of the safety and validity of a similar design or material Comparison of design to a previous proven product design Full clinical evaluation

When using comparison with a proven design, review the appropriateness in relation to the new application as part of the design validation process. When using a standard as the source of a validation procedure, specify the standard and ensure it is applicable. 6.3 Planning for Design Validation During the Planning Phase of the Product Development Cycle, the Product Manager and the Executive Management Team integrate validation tasks into the Product Development Plan. Identify and establish the performance characteristics to assess the validation methods, procedures, acceptance criteria, and desired end points. Ensure the acceptance criteria are traceable to the design input requirements detailed in the Marketing Requirements Document. Both the Executive Management Team and Product Development Team review the validation planning for appropriateness and completeness, and ensure it addresses user needs and intended use(s). Be vigilant in making validation tasks explicit, measuring the thoroughness of their execution, and documenting the results in detail.

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 4 of 6

[Company Name] [Company Group, Division, Location]

Design Validation [Document Number] Rev x.xx DD/MM/YY

As the design validation proceeds, revise and update the Product Development Plan. If design changes occur during validation, ensure validation testing remains valid or is later repeated for the product design. 6.4 Conducting Design Validation The Product Development Team is responsible for the conduct of design validation in the appropriate phases of development. As previously stated, validation consists of tests, inspections, analysis, or any other methods establishing conformance with user needs and intended use(s). Prior to conducting a validation task, establish in writing the evaluation criteria, the method of validation, and a detailed procedure in a Validation Test Plan. This plan is the written procedures and protocol to conduct field-testing or clinical trials of a product for design validation. It establishes with objective evidence that product specifications conform to user needs and intended use(s) and confirms the validity of the design input requirements detailed in the Marketing Requirements Document in the customer's use environment. The following are some basic principles to apply in conducting design validation.

Do not use the most skilled workers or technicians to fabricate the product used for validation testing. Instead, produce the test units under conditions simulating, as closely as possible, actual production. Include packaging and labeling design in the product validation process. These have significant human factors implications and may affect product performance in unexpected ways. Ensure validation addresses the expected environmental conditions of use, shipping, and storage, such as temperature, humidity, shock, vibration, etc. Take care to distinguish between customers, users, and patients to ensure validation comprehends the needs of all relevant parties.

Design validation normally follows successful design verification. It forces reconsideration of the design input and whether user requirements were properly conveyed to the designers. When validation identifies a problem, implement corrective action at the point in the design process corresponding to origination of the problem. 6.5 Documenting Design Validation Activities Immediately upon completion of a validation task, complete a Technical Report for Design Validation. Include an identification of the design under evaluation, the validation method and procedure, the date, and the individuals performing the validation. Record results, analysis, interpretations, and the operating conditions during validation. Remember that evaluation of the results is as important as the process itself. The Product Manager will add the Validation Test Plan and the technical report to the Design History File along with the results of all other validation activities and tasks. Design validation is the compilation of the results of all validation activities and may include several Technical Reports for Design Validation and other documents. After completion of all validation tasks for a specific product design, the Product Development Team should summarize the results in a validation report. 6.6 Review of Design Validation Formal design reviews are an important part of the design validation process. The primary purpose of System Design Reviews is design validation. Reviewers will review validation methodology, results, analysis, interpretations, and conclusions. During the review process, reviewers determine the adequacy of validation activities while considering factors such as conflicting user needs, unforeseen constraints, etc. Reviewers will also confirm traceability of validation acceptance criteria to the design input requirements detailed in the Marketing Requirements Document. Validation may expose deficiencies in the original assumptions concerning user needs and intended uses. The reviewers must resolve deficiencies with corrective action if the deficiency is not judged insignificant or erroneous.

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 5 of 6