#2 - 5 key questions every medical device manufacturer should ask

Medical device manufacturers must establish and follow quality systems in accordance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (CGMP) to ensure that devices are safe and function as intended. The quality system regulation (QSR) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.”

It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeting these requirements, which involves creating or selecting a quality management system (QMS).