The agency has made a lot of educational materials available, but the single most important source of information is the preamble. If I could get across one point to manufacturers, it would be to read that document. A. Not really. The quality system regulation is very broad and has been designed to cover a wide range of products. There are many kinds of medical device technologies, each with its own risks.
Manufacturers know their own products and the risks they carry.
Each manufacturer has to develop a quality system program commensurate with the products it's developing, keeping in mind the size of the company. The questions that a manufacturer has about the regulation will tell it what needs to be justified, and that will lead the manufacturer to the point of considering what type of quality system to establish and how to justify that system. Companies have to adjust their procedures to fit their own cultures, but for most companies simpler is probably better. But companies have to find a middle ground. Their procedures shouldn't be so strict that they offer the company only one way to satisfy the requirements, nor should they be so loose that the company doesn't derive any benefit.