The client was a US-based manufacturing company of Orthodontic devices, willing to expand their product in New Zealand, Australia, Japan and Brazil. Quite unaware of the device regulations in the respective countries, the client approached Freyr for device registration and license holding services. Though the 510(k) application and MDSAP certification of the device was under the US FDA review and assessment, the client was looking forward for obtaining CE certification. Additionally, the client had no local connect in the respective countries and faced linguistic barriers in the Brazilian and Japanese markets. However, Freyr managed to provide detailed evaluation and classification of the device, as per the country-specific regulations and acted as a Brazilian Registration Holder (BRH), sponsor and Australian sponsor in the Brazilian, New Zealand and Australian markets, respectively.

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