Freyr Solutions

To obtain a CE marking successfully, Freyr assists in adhering the conformity requirements needed. Further our experts support in device classification, technical file compilation, online registration and all other Regulatory processes so as to navigate the pathway compliantly and make a successful registration. Check out more at:  Medical Device Regulatory Services in Netherlands 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 Notification/Registration of Medical devices through Notis online registration system 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 Represent...

Freyr , as a strategic Regulatory partner, provides end-to-end Medical Device Regulatory services that span across quality control, classification, clinical safety and market access. We assist clients in all the procedural challenges right from Regulatory intelligence to dossier preparation and submission to product registration. Check out more at:  Medical Device Regulatory Services in Japan Freyr Expertise Quality Quality Management System (QMS) Good Quality Practice (GQP) QMS application to PMDA Preparation for PMDA inspection Local product release SOP writing Quality manual writing FMA application Due diligence audits Clinical CRO oversight and management Product development In-country Caretaker (ICC) for clinical trials in Japan Clinical trial notification (CTN) Safety Receipt, review and coding of adverse events Safety Reports to PMDA Good Vigilance Practice (GVP) Post-marketing Surveillance (PMS) studies Market access Market-access, pri...

With a growing demand for comprehensive medical devices, Italy stands as one of the largest medical devices market in Europe. The Directorate General for Medical Devices and Pharmaceutical Service of Ministry of Health is the competent authority responsible for regulating the import, marketing and trade of medical devices in the country. As a mandate, all Medical Devices must be registered with the Ministry of Health prior to their market entry, to obtain which, they must perform a CE certification conformity assessment submitting relevant technical documents. With no online registration system, application forms along with required documents must be submitted to Ministry of health via email or by post/ hand delivery. Obtaining a CE Certification could prove challenging since it is a long process involving compilation of numerous documents as specified by the EU device laws.  Freyr  offers end-to-end Regulatory services for Medical Devices and authoritative Regulatory inte...

Freyr  has dedicated expertise for supporting device manufacturers in obtaining CE marking. Our experts assist in device classification, product notification/registration, technical file preparation, etc. in compliance with the EU and ANSM regulations for successful device approval and market-entry. Check out more at:  Medical Device Regulatory Services in France 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 Notification/Registration of Medical Devices with ANSM Registration of Foreign Medical Device Manufacturers in France 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 ...