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.