Overview:

A 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective and substantially equivalent, to a legally marketed device .

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ABOUT GLOBAL REGULATORY PARTNERS

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 South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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