The Client is a US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets. Client’s expertise and geographical locations were limited to North America and was seeking a strategic partner to help expand its global market base.
GRP’s team brings decades of experience with registration of medical devices worldwide across LATAM, Europe, Asia, Africa, Middle East and North America. GRP’s offices in these regions makes GRP standout as a partner of choice for devices companies seeking a Global Regulatory Partner. GRP conducted strategic workshops with Client’s commercial and regulatory teams to assess their commercial markets of priority and provide a regulatory landscape based on their current status of registration.
The strategy was based on device’s potential class in global markets of interest to develop a harmonized approach.
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