Author: freyrsolutions

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

Freyr provides labeling and promotional material regulations support for medical devices manufacturers, which include label creation and review of IFU (Instructions for Use), UDI compliance, GAP analysis, comprehensive artwork check,... Read More

Freyr provides end-to-end medical device labeling services for medical device manufacturers that span across label creation, review of IFU (Instructions for Use), Gap analysis, UDI, EUDAMED and EU MDR label... Read More

Freyr provides regulatory support for medical device manufacturers in device technical file publishing, which include creation, review, validation, compilation and device technical file submissions in electronic format to meet country... Read More