US & EU Regulations for Medical Devices and Medical Device Manufacturers

All medical device manufacturers share a common difficulty! A medical device is only valuable when it’s available. And to be available, a device must be approved. And every market requires its own approval. Without pre-market approval, no device can be sold, no revenues can be generated and no growth can be obtained. The future of medical or diagnostic device manufacturers does not only depend on their ability to innovate, it equally depends on their ability to get their products to market. The lecture will give an overview on the conceptual basis and the challenges faced by developers of medical equipment, meeting the regulatory world, Starting from the basic R&D concept and the excitement and understanding that there is a new product that we want to develop and market, it is necessary to understand the what will be the processes required that will enable the domestic marketing clearances and approvals. The focus in this lecture is overview of basic regulatory requirements in particular- the European and American regulatory