Freyr provides regulatory support to the medical device manufacturers in De-Novo registration of medical devices in the USA that span across classification, Pre-Submission/Q-Submission meeting request, risk benefit determination, De-Novo submission package compilation, publishing and creation for Pre-Submissions.
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Freyr’s regulatory services in USA for Diagnostic Kits span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Freyr’s regulatory services in USA for Ultrasound Machines span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.