Redefining Medical Device Labeling Initiatives
Medical device labeling is an essential step in bringing a product to the market. It plays a significant role in informing consumers about any potential hazards associated with the purchased products. The FDA's Center for Devices and Radiological Health receives approximately 100,000 medical device event reports each year, with usage error accounting for around a third of these reports. When it comes to approving medical devices, the labeling process requires careful attention to detail. The failure to include critical information or labeling products incorrectly can have serious consequences for manufacturers. Therefore, medical device labeling reviewers and manufacturers must ensure that they adhere to the regulations and guidelines that have been put in place to protect patient safety. It is also crucial to comply with different countries' regulations and the global market's standards when marketing products in various countries.
LTTS has extensive expertise in managing regulatory compliance engagements spanning multiple regions and is a key partner for various leading medical device manufacturers globally. The company performs thorough reviews of labeling materials to ensure compliance with the latest mandatory regulatory guidelines and symbols, collaborating with regulatory specialists to identify any discrepancies or non-compliance for medical devices marketed across different countries.