Title: Material Controls
Course: BTEC-1300-301-302-303-F21 > Section: Quality System Regulations and the Quality Management System

A manufacturer has to prove to the FDA through documentation that any materials they put into their medical devices are not going to adversely affect the device or the manufacturing process. Manufacturers must also provide evidence that the suppliers of the various materials have been evaluated for compliance with regulations.

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.