Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
Determining and setting up a quality system is a challenging task for medical devices manufacturers. A robust quality system covers the aspects like the medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management and complaint handling. The US FDA maintains a Quality System Regulation (QSR), which ensures that all the medical devices sold in the USA are safe, quality-oriented and effective for their intended use.