The “EU IVDR” category at AssurX focuses on helping organizations comply with the European Union’s In Vitro Diagnostic Regulation (IVDR). This section provides insights into quality management, compliance strategies, and process optimization tailored for in vitro diagnostic device manufacturers. Key topics include understanding the IVDR requirements, ensuring product safety, and maintaining high standards of quality and performance. With AssurX’s expertise, professionals can navigate the regulatory landscape, enhance operational efficiency, and drive innovation to meet all necessary EU IVDR standards.
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04, 2023
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]
