FDA Statements

• Each manufacturer shall establish and maintain procedures for verifying the device design.
• Design verification shall confirm that the design output meets the design input requirements.
• The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section F:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720788
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf)
• Section 820.30(f) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.7 Design verification

Mapping

The following process elements satisfy this objective:

• Verify and Validate Functional Requirements
• Verify Collaborations
• Verify Statecharts for each Subsystem
• Perform Rainy-Day Analysis
• Prepare for Verification and Validation
• Verification and Validation
• Test Iteration [Template]
• Test Iteration [Management]

More information:

• Independent Testing
• Test Management