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start [2024/03/18 17:44] rudy [PMA.core gives you regulatory compliance] |
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. | + | PMA.core is** CE-IVD certified for in vitro diagnostic use** for making diagnosis and measurements on all compatible image file types. |
| 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|}} | ||
| ==== Peace of mind ==== | ==== Peace of mind ==== | ||
start.1710773059.txt.gz · Last modified: 2024/03/18 17:44 by rudy
