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Medical Devices and in-vitro diagnostics (IVD) registrations and submissions are very specific and different for every Health Authority. As per the regional Regulatory standards, expertise in compilation of all necessary information into Technical File, Device Master File, Design Dossier and Design History File helps in faster reviews and approvals of the devices.
Freyr has a strong Regulatory team to handle Medical Devices and IVD submissions and registrations effectively for all major Health Authorities like the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA) etc. Either premarket notification or premarket application or for classification of devices, Freyr has the global expertise to ensure compliant market-entry for devices.
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