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start [2025/11/06 18:53] rudy |
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| PMA.core is** CE-IVD certified for in vitro diagnostic use** for making diagnosis and measurements on all compatible image file types. | PMA.core is** CE-IVD certified for in vitro diagnostic use** for making diagnosis and measurements on all compatible image file types. | ||
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| + | PMA.core 3.0 complies with the provisions of EU Directive 98/79/EC on in vitro diagnostic medical devices.It has been validated for diagnostic use in histopathology of scanned slides stained with hematoxylin and eosin (HE), immunohistochemical (IHC) stainings or in situ hybridization (ISH) and meets the validation criteria of the College of American Pathologists (Evans et al, Arch Pathol Lab Med 2021) for diagnostic use of whole slide images for these applications. This document complies with the requirements of EU Directive 98/79/EC and MEDDEV 2.14/3 rev.1 on instructions for use for in vitro medical devices. | ||
| Our unique device information can be found in the Eudamed database | Our unique device information can be found in the Eudamed database | ||
| {{:eudamed_udi.png?600|}} | {{:eudamed_udi.png?600|}} | ||
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| ==== Peace of mind ==== | ==== Peace of mind ==== | ||
start.1762444416.txt.gz · Last modified: 2025/11/06 18:53 by rudy
