News

New UDI Regulation for IVD by ANVISA in Brazil The National Health Surveillance Agency (ANVISA) has taken a groundbreaking step with the approval of the Resolution de Diretoria Colegiada (RDC)…

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SFDA- The Saudi Arabian authority for medical products The Saudi Food and Drug Authority (SFDA) is the institution in Saudi Arabia responsible for regulating and overseeing medical devices and health…

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Test your knowledge about UDI Barcode with our new quiz! What are UDI Barcode? Barcode plays a crucial role in the Unique Device Identification & traceability of medical devices to…

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UDI Compliance (Audit-Trail & Compliant Software) The implementation of the UDI system worldwide poses a challenge for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted and…

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UDI Barcode & Correct UDI Labeling Identification and traceability of medical devices are crucial factors for patient safety and efficiency in the medical device industry supply chain. In this context,…

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Test your knowledge about UDI with our interactive quiz! What is UDI? UDI plays a crucial role in the traceability of medical devices to ensure safety and compliance. But how…

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What sanctions are there for non-compliance with UDI requirements? Compliance with Unique Device Identification (UDI) requirements is not only crucial for companies in the MedTech sector but is also accompanied…

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"Maximum number of reuses of device" in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the EUDAMED…

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It's with great pleasure that we welcome Alexander Kaesler as a new SAP consultant in our team at Europe IT Consulting! From now on, Alexander will work as an SAP…

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