I found a presentation that was put together by BioTechLogic to address this issue ( It seems like it is a very involved process and I've just listed the major steps below: 1. Quality System Gap Asses...

It's important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices...

I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts...