An UK-based company with a major portfolio of Pharmaceuticals, OTC products and few Medical Devices, approached Freyr for end-to-end Regulatory services pertaining to device registration in the USA. The client had two variants of a device, which were CE marked, the predicates of the device were identified and actively distributed in the EU region. However, though the predicates were identified, there was no established evidence of substantial equivalence between the devices. In addition, the client was not aware of the USA Regulatory requirements and there were some gaps in the biocompatibility testing data, which was challenging.
How did Freyr overcome the challenges and followed a phase-wise approach for a hassle-free device registration? Discover with this proven case.