Change Control: Considerations For Medical Device Components

By Paul Priebe

Many factors, such as supply chain problems, design modifications, inter-device compatibility, or component manufacturer changes, may lead to changes in medical device components. Based on the various causes for component changes, processes must address changes driven from the supply side and from the manufacturer of the finished medical device.

Explore the various factors that must be considered when faced with such modifications, and what processes must be implemented in advance as part of a robust Quality Management System.