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Tag devices

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  • Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR
18. June 2024

Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR

By Ismail Demiralp In News Tag devices, MDR 2017/745, Unique Device Identification
Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR

Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR The European Medical Device Regulation (MDR 2017/745) provides clear definitions and requirements for various categories of products in…

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15. December 2020

Fachartikel auf www.pressebox.de

By Ismail Demiralp In News Tag cloud, corona, devices, erp, EUDAMED, FDA, GUDID, IVDR 2017/746, MDR, MDR 2017/745, medical, SAP, spl, UDI

Handlungsbedarf für Medizinproduktehersteller im Bereich UDI GUDID / EUDAMED Was für Lebensmittel heute bereits gilt, wird auch für Medizinprodukte Realität. Die Rückverfolgbarkeit muss sichergestellt werden, mit dem übergeordneten Ziel, die…

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30. April 2020

Action required for medical device manufacturers in the UDI sector

By Ismail Demiralp In Technical article Tag cloud, corona, devices, erp, IVDR 2017/746, MDR 2017/745, medical, spl
Action required for medical device manufacturers in the UDI sector

GUDID / EUDAMEDWhat already is true for food today is also becoming reality for medical products. Traceability must be ensured, with the overriding goal of optimizing patient safety. Preparations at…

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