By James Jardine, GxP Lifeline Editor, MasterControl
Medical device manufacturers are always under intense pressure to develop innovative, high-quality products faster and at the lowest possible cost. Staying competitive means medtech manufacturers must respond to customer demands quickly and adapt to change even faster.
Doing business in a regulated industry requires that device manufacturers not only contend with innovative competitors, but also strive to comply with stringent International Organization for Standardization (ISO) quality requirements and U.S. Food and Drug Administration (FDA) regulations. To meet applicable standards and regulations, medical device companies must control, manage, and document any changes to their processes. Failure to adequately manage change control in medical device production can negatively affect the safety and reliability of devices. It's not an exaggeration to say that poor change control can have a direct impact on the health and safety of the public.