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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 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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