HI All,

While reading through the FDA Design Control Guidance pdf, I came across this section,

Can someone answer the following two Q’s?

The quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device. This raises two fundamental issues for developers:

What constitutes design output?

Are the form and content of the design output suitable?