The medical industry stands out from other aspects of manufacturing. The inspection rates are often higher, quality is paramount, and the products could be implanted into the human body.

Quality 4.0 derived from Industry 4.0, also known as the fourth industrial revolution. Prior to the fourth revolution, the first revolution started with machine manufacturing, steam power, and the move to cities by agriculturalists. 

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.