Main components:

• Preliminary and final specifications for the design phase
• All documentation from User Requirements through C-Level Specs, Test Documentation and Source code and CAD/CAM drawings.FDA Statements

FDA statements

• Each manufacturer shall establish and maintain a DHF for each type of device.
• The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section J:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720792
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(j) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.1.6 Control of quality records