Medical Device

Drug-Device Combination Products | Innovations and Compliance

Drug-Device Combination Products | Innovations and Compliance

In the ever-evolving landscape of medical technologies, drug-device combination products represent a cutting-edge integration of drugs, medical devices, and biologics. These products offer innovative solutions for disease management, but they also demand a robust understanding of regulatory frameworks and compliance to ensure safety, efficacy, and quality. What Are Combination Products? ... Read More
Medical Device Labeling Regulations

Medical Device Labeling Regulations

Prominence and Conspicuousness: According to FDA regulations, all required information on medical device labels must be highly visible and easily understood. This is essential to ensure that users can access important information about the device when making a purchase. The failure of label information to meet these requirements can result ... Read More