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Table of Contents
1.0 Purpose..........................................................................................................................................................2
2.0 Scope.............................................................................................................................................................2
3.0 Definitions.....................................................................................................................................................3
3.1 Customer............................................................................................................................................3
3.2 Design History File (DHF).................................................................................................................3
3.3 Design Input.......................................................................................................................................3
3.4 Design Output....................................................................................................................................3
3.5 Design Review....................................................................................................................................3
3.6 Design Validation...............................................................................................................................3
3.7 Device Master Record (DMR)...........................................................................................................3
3.8 Process Validation..............................................................................................................................3
3.9 Product...............................................................................................................................................3
3.10 Product Development.........................................................................................................................3
3.11 Quality................................................................................................................................................3
3.12 Quality System...................................................................................................................................3
3.13 Specification.......................................................................................................................................4
3.14 Validation...........................................................................................................................................4
3.15 Validation Test Plan...........................................................................................................................4
3.16 Verification.........................................................................................................................................4
5.0 References.....................................................................................................................................................5
6.0 Procedure......................................................................................................................................................5
6.1 Purpose of Design Validation.............................................................................................................5
6.2 Validation Methods............................................................................................................................5
6.3 Planning for Design Validation.........................................................................................................5
6.4 Conducting Design Validation...........................................................................................................6
6.5 Documenting Design Validation Activities.......................................................................................6
6.6 Review of Design Validation..............................................................................................................6
1.0 Purpose
This procedure defines the process for conducting and documenting design validation 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 Customer
Anyone purchasing, using, operating, or interfacing with a product in any manner.
3.9 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.
3.11 Quality
The totality of features and characteristics that bears on the ability of a product to satisfy fitness-
for-use, including safety and performance.
3.13 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.
3.16 Verification
Confirmation by examination and provision of objective evidence that specified requirements
have been fulfilled.
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
6.0 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).”
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.
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.
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.
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.