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QUAREGIA is a consultancy spezializing in providing Quality & Regulatory Affairs Services for Medical Devices, Medical Device Software, In Vitro Diagnostic Devices, and Combination Products CE Marking, Product Approvals, Technical Files, Risk Management, Usability Engineering, Requirements Engineering, Remediation, Process Validation Medical Device Software: Software Safety and Cybersecurity, Artificial Intelligence, Data Protection, Software Lifecycle Process, CSV, Medical Device Software Documentation

Medical Devices, ISO 13485, Quality System Regulations, 21 CFR Part 820, SOR/98-282 (CMDR), IEC 62304, IEC 60601-1, IEC 62366, MDD 93/42/EEC, AIMD, Drug Delivery, Project Management, Project Portfolio Management, Life-Cycle Management, ISO 14971, Risk Management, GAMP 5, Process Validation, CSV, 21 CFR Part 11, Software Validation, Regulatory Affairs, Responses to FDA-483, Warning Letters

Worldwide product registration strategy, product registrations in the USA (FDA), EU, Japan, Canada, etc.; Maintenance of technical documentation the products; Quality Management System and certification according to ISO 13485, MDD 93/42/EEC, QSR, CMDCAS, etc; QA (establishment and maintenance of a CAPA system, performance of quality review meetings, responsible for releases under concession and monitoring of actions);

- Project Manager Device Development - Technical Writer (Manuals, Technical Documentation)

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