We help Medical Device and In Vitro Device companies in Europe with new Medical Device Regulations(MDR) and new In Vitro Device Regulation(IVDR), helps in developing CER as per EU MDR guidelines

Freyr assists medical device manufacturers with 510k submission(510k premarket notification) support which include 510k compilation, E-submission of 510 (k) to FDA, FDA queries support, Medical Device listing and FURLS database maintenance

Freyr provides regulatory compliance, gap analysis & remediation services to Medical device companies which span across UDI, GDPR, EUDAMED compliance support, Software validations, SOP development/reviews, Preclinical & clinical Regulatory support, Technical files/design dossiers, internal & external audits, and gap assessment.

Freyr has extensive global expertise in Quality Management System (QMS) Compliance Services to support medical device manufacturers in establishing quality systems compliant with ISO 13485, FDA 21 CFR part 820, and other QMS requirements as per region specific health authority.

Freyr helps in developing clinical evaluation Report(CER), preparing, upgrading existing CER, CE Technical File, Gap analysis, Clinical expert review as per European Medical Device regulations to medical devices manufacturers in Europe.

Freyr acts as an authorized representative on behalf of the foreign medical device manufacturers and support for registration, Pre-Certification, Post Approval, marketing authorization holder (MAH) services, Interaction in local language in APAC, LATAM, Europe as per the regional specific Health Authorities.

Freyr offers Medical Device Regulatory services that span across Medical Device registration, classification, licensing, labeling, listing, labeling review, IVD classification, technical & master file Compilation, Market approvals to comply with US FDA, EMA & Health Canada