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

Equipment and facility controls relate to requirements for the facility where medical devices are manufactured. They cover such things as physical space requirements; cleanliness; ventilation; equipment inspection, maintenance, and calibration; and employee health and cleanliness,.

This is part of what the FDA is doing when they conduct a pre-approval inspection. They need to be assured that the facility and equipment are adequate for manufacturing medical devices.

Learning Objectives:

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