Question

According to the QSR, Design Outputs contain the following:

A) The Device Master Record (DMR)
B) The documentation from the last phase of the complete Design Control process
C) The test reports that support that the Design Inputs have been met
D) All of the packaging and labeling associated with the finished device
E) A and D above

Answer 1

Design Outputs according to the QSR include test reports verifying Design Inputs and all of the packaging and labeling for the finished device.

Step-by-step explanation:

These outputs include detailed schematics, test reports that support that the Design Inputs have been met, and all packaging and labeling associated with the finished device. Thus, while related to the outputs, it itself is not an output.

The Device Master Record (DMR) is not directly a part of Design Outputs; it is a compilation of all the instructions, drawings, and other records that must be followed to produce a product. The DMR comes into play after the design phase is completed.

Communication of the design process and its results is an essential final step in the design process, ensuring that all required parties have the necessary documentation to understand and implement the design, be it for production, maintenance, or further development.