Regulatory submissions throughout the world comprise two major components. The first is the record of all the tests which show the device does what it says it does in a way which minimises risk to the patient, user and others. Variously called a submission for 510(k), PMA, Technical File, Design Dossier, wrapped up into the term Technical documentation.

 The second is the demonstration that this device can be made to the same standard repetitively, and there are records to prove it. That is the Quality system.