The formal review of an existing or proposed design to detect and remedy deficiencies that could affect fitness for use and environmental aspects of the product, process, or service, and to identify potential improvements in performance, safety, or economy.

In the cGMP for Medical Devices, Final Rule, DESIGN REVIEW means 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 these requirements, and to identify problems.

FDA Statements

• Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.
• The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
• The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section E:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720787
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(e) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.6 Design Review

Mapping

The following process elements satisfy this objective:

• Reviews
• Reviewer
• Review Coordinator
• Systems Engineering Workflow

More information:

• Reviews