The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the Device Master Record. The total finished design output consists of the device, its packaging and labeling, and the Device Master Record.

Set of specifications written in response to the requirements specifications and constraining standards and regulations, i.e., Design Inputs. Specifications include System Specifications, Subsystems Specifications, Test Results, etc.. A subset of the Design History File

FDA Statements

• Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.
• Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
• Design output shall be documented, reviewed, and approved before release.
• The approval, including the date and signature of the individual(s) approving the output, shall be documented.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section D:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720786
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(d) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.5 Design Output

Mapping

The following process elements satisfy this objective:

• System Architecture Model
• Platform Independent Model
• Platform Specific Model
• Interface Control Document
• Physical Inteface Control Document (pICD)
• Subsystem Requirements Specification 

More information:

• Architectural Design - Use-Case Based
• Real-Time Architectural Design