EU Reference Labs

EU Reference Labs

SOFTWARE MD/IVD NEWS August 23, 2022

The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU) 2017/746 specifies the requirements that must be met by EU reference labs. In order to assure adherence to these standards,…

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Multiplex #IVD devices | Assessment Common Approach

Multiplex #IVD devices | Assessment Common Approach

SOFTWARE MD/IVD NEWS August 23, 2022

Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose. They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to…

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AI and the Software as a Medical Device

SOFTWARE MD/IVD NEWS 27 November, 2021

Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.