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start [2025/11/06 15:51] rudy added paper manual option to meet Medical Device regulations |
start [2026/01/12 11:21] (current) angelos |
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| - | **__NOTE__**: A user manual on paper or in .pdf format version of these pages is available upon request including translations to your local language. Please contact us at [[info@pathomation.com]] to ask. | + | **__NOTE__**: A user manual on paper or in .pdf format version of these pages is available upon request including translations to your local language. Please contact us at [[info@pathomation.com]] to ask. Please allow 10 days for processing and shipping for paper requests. |
| - | ====== About PMA.core 3.0.6 ====== | + | ====== About PMA.core 3.0.7 ====== |
| PMA.core manages your whole slide images. It operates through web protocols and supports [[supported_file_formats|a number of file formats]], allowing you to manipulate WSI data from different vendors in a standardized manner. This enables efficient management of digital slide images while requiring minimal setup. | PMA.core manages your whole slide images. It operates through web protocols and supports [[supported_file_formats|a number of file formats]], allowing you to manipulate WSI data from different vendors in a standardized manner. This enables efficient management of digital slide images while requiring minimal setup. | ||
| - | [[what_s_new_in_version_3.0.6|Click here to see what's new in release 3.0.6]]. Alternative, you can still follow [[https://docs.pathomation.com/pma.core/3.0.5|this link if you're looking for the wiki of PMA.core 3.0.5]]. | + | [[what_s_new_in_version_3.0.7|Click here to see what's new in release 3.0.7]]. Alternative, you can still follow [[https://docs.pathomation.com/pma.core/3.0.6|this link if you're looking for the wiki of PMA.core 3.0.6]]. |
| {{:pmacore_3_dashboard.png?direct&600|}} | {{:pmacore_3_dashboard.png?direct&600|}} | ||
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| The software acts as an [[honest broker|honest broker]] between the [[supported_file_formats|various vendor-dependent file formats]] on one end, and a variety of different end-user applications on the other. | The software acts as an [[honest broker|honest broker]] between the [[supported_file_formats|various vendor-dependent file formats]] on one end, and a variety of different end-user applications on the other. | ||
| - | [[what_s_new_in_version_3.0.6|Find out what's new in version 3.0.6]] right away. | + | [[what_s_new_in_version_3.0.7|Find out what's new in version 3.0.7]] right away. |
| ==== PMA.core gives you regulatory compliance ==== | ==== PMA.core gives you regulatory compliance ==== | ||
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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.1762433496.txt.gz · Last modified: 2025/11/06 15:51 by rudy
