Freyr Solutions

Freyr provides Medical Device Classification, Registration in India, Licensing, Authorized Agent Representation, Document Compilation, Regulatory Assistance for Form MD-14 Application, Post-Market Surveillance to comply with Central Drug Standard Control Organization (CDSCO) under DGCI – Freyr Webpage Link – Medical Device Registration in India Freyr Expertise Medical Device Classification Indian Authorized Agent Representation Documents Compilation Regulatory Assistance for Form MD-14 Application Liaison with Local Health Authority Post-Market Surveillance

Freyr offer Regulatory services for Medical Device & IVDs that includes registration with EMA, licensing, EU-MDR Transition, Classification, Dossier Review, Compilation & Submission, CE mark & ISO 13485 certification, provides support to certify medical devices from TUV, DQS, DEKRA, SGS in Germany region – Freyr Webpage Link – Medical Device Registration in Germany Freyr Expertise European Medical Device Classification ISO 13485 Compliance CE Technical File or Design Dossier Review, Compilation and Submission EU-MDR Transition and Support Clinical Evaluation Reports (CER) for Medical Devices ISO 14971 Risk Management Consulting Medical Device Regulatory Strategy Report Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance Labeling and GMP Support Post-market Monitoring and Adverse Event Reporting European Authorized Representative Support

Freyr offers Medical Device registration in China, classification, labeling, licensing, Clinical trial support, local agent representation, Dossier compilation, Linguistic Translation Support for Submission Documents to comply with China Food and Drug Administration’s (CFDA) & Centre for Medical Device Evaluation (CMDE) – Freyr Webpage Link – Medical Device Registration in China Freyr Expertise Regulatory Assistance for Registration Medical Device Classification Clinical Trial Support Chinese Local Agent Representation Testing Data and Dossier/Documents Compilation Assistance for Listing Product Technical Specifications Linguistic Translation Support for all Submission Documents Post-Market Surveillance

Freyr offers Medical Device establishment license, registration, classification, authorized representation, support for CMDCAS (ISO 13485) Certification, Document Compilation & Submission to comply with medical device regulations(MDR) of Health Canada – Freyr Webpage Link – Medical Device Registration in Canada Freyr Expertise Regulatory Assistance for Establishment License Procurement Medical Device Classification Support for CMD CAS Procurement Document Compilation and Submission Support Post-market Surveillance

Freyr provide Medical device registration, classification, Local representation, Document compilation, Brazil Registration Holder (BRH), regulatory support to acquire Brazilian Good Manufacturing Process (BGMP), INMETRO Certification & GMP/MDSAP to comply with ANVISA. – Freyr Webpage Link – Medical Device Registration in Brazil Freyr Expertise Medical Device Classification Brazil Local Representation Regulatory Support to acquire Brazilian Good Manufacturing Process (BGMP) Certification Support for Procuring INMETRO Certification Document Compilation for Cadastro and Registro Processes Post-market Surveillance