Do or Demise: Why It’s Crucial for Medical Device Manufacturers to Adhere to the FDA’s ABCs

Medical device manufacturers frequently face unique industry challenges, including the need to manage quality processes across disparate sites or business units and increased legal and regulatory scrutiny. The FDA requires that each medical device comply with a standard set of guidelines to ensure quality is upheld. In order to validate that this criteria is being met, the FDA states that all medical device manufacturers have some form of quality management system (QMS) in place to define, communicate, measure, and improve key company processes. QMS is intended as the tool to manage the quality system regulations imposed by the FDA. Though implementing a QMS is required by law, this article examines additional business benefits associated with using a QMS.