An US-based leading manufacturer of hearing implants approached Freyr to provide end-to-end Regulatory support for venturing into the Sri Lankan market. As the device had accessories with multiple variants, the grouping was challenging. In addition, the client was unaware of the NMRA regulations, device registration process and procedures. However, Freyr acted as an authorized representative for the client and carried out all the detailed evaluation and phase-wise registration for the devices.
Discover how Freyr overcame the challenges and provided a hassle-free device registration process for the client. Download the proven case.
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