Medical device labeling forms a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging with an intent to increase the safety and usage instructions for the consumers.
Globally, misbranding and mislabeling have increased the medical device recall rate by 15%. According to the latest consensus, devices with 510k approval account for 71% of high-risk recalls. It indicates an alarming snapshot of the industry’s quality issues and a potential threat to public health. Soaring recalls lead to serious long-term reputational and financial damage. Between 2017 and 2019, 5.9% of the device recalls were attributed to mislabeling. Nearly 4,500 devices are pulled down by the US FDA annually.
Freyr’s medical device experts are relentlessly engaged in providing end-to-end labeling services throughout the device’s life cycle. We analyze, review, track, update, and maintain label changes for device manufacturers and provide labeling solutions right from device conceptualization to final artwork publication.