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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 Staff Augmentation Consulting services for medical device manufacturers that span across several Regulatory functionalities from associate to expert level resources and 24X7 time zone coverage model to support multiple time zone and office coverage.
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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 regulatory intelligence services for medical device manufacturers to meet region-specific health authority requirements for compliant market entry of their products and provides comprehensive regulatory Intelligence reports corresponding to organizational needs basing on the region and device type.
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Freyr provides medical device regulatory compliance, gap analysis and remediation services for medical device manufacturers that span across UDI, GDPR, EUDAMED compliance support, post approval compliance support, Consultation and representation services for ISO 13485:2016, MDSAP, BGMP and establishment of QMS document
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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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