Atualizações recentes
-
Medical Device Biocompatibility TestingMedical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. Biocompatibility testing evaluates the effect of a medical device on human tissues to determine whether it can cause biological reactions such as toxicity, physiological, immune, or mutation. Biocompatibility testing is a key process to ensure the safety and...0 Comentários 0 Compartilhamentos 2KB Visualizações 0 AnteriorFaça o login para curtir, compartilhar e comentar!
-
What Are the Steps of the 510(k)-submission Process?People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device...0 Comentários 0 Compartilhamentos 2KB Visualizações 0 Anterior
-
Proregulations' Comprehensive Regulatory Consulting Services Help Gain a Competitive Edge in the North American MarketProregulations is a newly emerging regulatory consulting firm that specializes in assisting medical device manufacturers and companies in navigating the complex process of registering their products with the U.S. Food and Drug Administration (FDA). With its comprehensive range of services, Proregulations helps medical devices to enter the lucrative North American market smoothly...0 Comentários 0 Compartilhamentos 2KB Visualizações 0 Anterior
-
0 Comentários 0 Compartilhamentos 372 Visualizações 0 Anterior
Mais stories