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The FDA Breakthrough Devices Program is a voluntary program that can be used by manufacturers of medical devices, and certain combination products, that provide more effective treatment or used to diagnose life-threatening or irreversibly debilitating disease or condition.
To know more, please check out our white paper
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.