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Freyr helps medical device manufacturers with language translation, editing of medical device technical information in IFU, DSURs, SUSARs, Package inserts & labels for submission & approval process as per targeted regional languages with compliance to ISO 17100:2015 & ISO 9001:2008 standards.
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Freyr provides regulatory supports for medical devices and In-vitro diagnostics (IVD) manufacturers in registration, regulatory submissions, dossier compilation, GAP analysis, premarket notification, local agent services and classification as per country-specific regulatory requirements for compliant market entry.
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Freyr provides regulatory strategy consulting services for medical device manufacturers looking for global expansion in complex markets like APAC, MENA & LATAM and supports in device registration, classification, assistance with notified body selection and regulatory submissions.
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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 provides labeling and promotional material regulations support for medical devices manufacturers, which include creation & review of IFU (Instructions for Use), UDI compliance, GAP analysis, comprehensive artwork check, tracking and maintaining label changes.
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Freyr provides labeling services for medical device manufacturers that span across label creation, review of IFU (Instructions for Use), Gap analysis, UDI, EUDAMED & EU MDR label compliance, tracking and maintaining label changes as per regulatory requirements.
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Freyr provides regulatory support for medical device manufacturers in device technical file publishing, which include creation, review, validation, compilation and device technical file submission in electronic format to meet country specific health authority requirements for compliance.
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