Tag: I3CGLOBAL

India’s Medical Device Industry Turns to I3CGLOBAL for Structured Global Compliance Support

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As global regulatory frameworks continue to evolve, Indian medical device manufacturers are increasingly seeking structured and transparent pathways for international market access. Supporting this transition is I3CGLOBAL a regulatory consulting firm assisting manufacturers in navigating the growing compliance requirements of the US FDA and European regulatory systems. Under the leadership of regulatory strategist Soio George, […]

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IVDR

IVDR CE Marking and the Challenges Faced by Indian IVD Manufacturers

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New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale manufacturers in India to access the European market faster. With the enforcement of the EU IVDR Regulation 2017/746, Indian in vitro diagnostic (IVD) device manufacturers are facing significant challenges […]

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