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GRP’s whitepapers provides an overview of international guidelines for Software classified as a Medical Device.
International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device known as (SaMD) as a software that is intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
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.