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start [2023/11/21 13:43] chris |
start [2024/03/25 16:22] (current) rudy [PMA.core gives you regulatory compliance] |
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PMA.core offers [[audit trailing|audit trailing]], [[21 CFR part 11]] compliance. Each release is also [[https://ispe.org/publications/guidance-documents/gamp-5|GAMP 5]] validated. | PMA.core offers [[audit trailing|audit trailing]], [[21 CFR part 11]] compliance. Each release is also [[https://ispe.org/publications/guidance-documents/gamp-5|GAMP 5]] validated. | ||
+ | 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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+ | Our unique device information can be found in the Eudamed database | ||
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+ | {{:eudamed_udi.png?600|}} | ||
==== Peace of mind ==== | ==== Peace of mind ==== | ||