Case Study 24: Registration of a Software as medical device in China, Columbia and South Korea for European AI based Company

Company Situation

The Client is a US based medical device company that developed a suite of innovative AI based software for multiple applications. The client has registered the software as medical devices in EU, USA, Canada, Australia, Brazil, Japan, Thailand and had planned to register in 10+ other global markets. With limited global presence and regional regulatory expertise, Client wanted a global partner to ensure their product approval in markets of interest.

GRP Solution

GRP with its extensive global experience with Artificial Intelligence based software as devices and regional presence across Americas, Asia-Pacific, Europe was preferred by client as one-stop-shop for all their regulatory and clinical needs. GRP was able to provide a harmonized global strategy for device registration in priority markets based on country specific timelines and documentation / testing requirements. GRP obtained licenses successfully in those markets and continues to be a partner to help Client expand in global markets. GRP services included the following:

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