FDA Statements

• Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section H:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720790
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(h) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.2.3(c) Quality planning

Mapping

The following process elements satisfy this objective:

• Preparation for Downstream Engineering
• Baseline

More information:

• Preparation for Downstream Engineering