Design validation is a cumulative summation of all efforts to assure that the design will conform with user needs and intended use(s), given expected variations in components, materials, manufacturing processes and the user environment.

FDA statements

• Each manufacturer shall establish and maintain procedures for validating the device design.
• Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
• 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, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section G:
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720789
• PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(g) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.8 Design validation

Mapping

The following process elements satisfy this objective:

• Verify and Validate Functional Requirements  
• Prepare for Verification and Validation
• Verification and Validation

More information:

• Build and Validate Use Cases