The Requirements of an Effective QM-System for MedTech Companies The worldwide introduction of the UDI system poses a challenge for manufacturers to comply with the regulations of the Unique Device…
MDR causes shortages of medical devices The introduction of Unique Device Identification (UDI) means that manufacturers of medical devices are obligated to provide a comprehensive range of product information to…
Introduction of the UDI system worldwide poses challenges for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted, and the path to compliance is highly complex. UDI…
Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. Focused on the realms of medical technology and life sciences, it serves as a platform bringing together companies,…
Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. Focused on the realms of medical technology and life sciences, it serves as a platform bringing together companies,…
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)…
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…
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…
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…
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,…