May - 20202celegenceRegulatory Affairs Business ServicesMedical Device Regulatory ComplianceCelegence provides experse for every step of the Medical Device product lifecycle management for RA, QA and Clinical Departments of Medical Device companies.We provide support in interpreng and operaonalizing country-specific requirements with depth and breadth of experience and proven processes. Our global team of experts will develop the opmal regulatory strategy for each medical device in your target market. We specialize in helping our clients reduce cost and me to market by providing flexible, informaon-based services. With regulatory experse that spans all types of products, our global regulatory consultants apply up-to-date, robust regulatory intelli-gence to support product development and submission strategies.Celegence's Medical Device Soluons Include:US: Pre-Market Authorizaon (510(k) applicaon process supportUDI ServicesEurope: Technical File Preparaon & SubmissionEmerging Countries: Country-Specific RegistraonsPrepare, write, edit, and review CEPs and CERsQC, eding and formang servicesRemediaon (Rev 3 to Rev 4) and Maintenance Updates (Rev 4) Post-Market Surveillance Plan, Post-Market Clinical Follow Up Plan and Post-Market Clinical Follow Up Report Summary of Safety and Clinical PerformancePeriodic Safety Update Report (Medical Device Specific) Regulatory strategy consulng - Provide reports on country-specific updates to Regulatory requirementsMedical Device Classificaons, licensing, registraons and renewalsGlobal regulatory consulng and intelligenceReview the current CER SOP/WI/Templates and providerecommendaons to ensure CERs meet MDR requirementsMonitor proposed and current global regulaons and guidance and provide advice on impact of such regulaons Offer both on and offshore soluonsRegion SpecificRegistraonSupportEU MDR ConsulngCER MedicalWringCER TemplateGap AnalysisMDR DocumentaonPreparaonCopyright @ 2020 Celegence. All Rights Reserved. For more information, please contact: info@celegence.com www.celegence.com
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