Design Validation

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Design Validation - short version

Testing to ensure that product conforms to defined user needs and / or requirements. Design validation follows successful design verification and is normally performed on the final product under defined operating conditions. Multiple validations may be performed if there are different intended uses.

Design Validation - long version

Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, shall be documented in the Design History File.

According to the Quality System Regulation, validation testing must be performed on actual production units or their equivalents. When equivalents are used, the manufacturer must provide documentation that clearly demonstrates the equality. There can be a tendency to manufacture test units under special conditions that do not mimic actual production. An example would be the manufacturing engineer performing final assembly on a device where this would normally be done by a manufacturing operator. The manufacturing engineer’s skill level and knowledge base are most likely different from those of the operator. Companies should strive to produce their test units in an environment as close to the final production environment as possible.


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