Keys To Managing Change Control Effectively In Medical Device Manufacturing

By James Jardine, GxP Lifeline Editor, MasterControl

Medical device manufacturers face constant pressures to develop cutting-edge, high-quality products as quickly and inexpensively as possible. To remain competitive, companies must not only meet customer demands promptly but also adapt swiftly to changes in the market. Operating in a regulated environment means that medtech manufacturers must navigate both fierce competition and strict compliance requirements from the International Organization for Standardization (ISO) and the U.S. Food and Drug Administration (FDA). To adhere to these regulations, companies must carefully control, manage, and document any process changes. Failing to effectively manage change control can compromise the safety and reliability of the devices, potentially putting public health at risk. It is no exaggeration to say that poor change control can have serious consequences for public safety.