[Al...] Posted April 6, 2022 Share Posted April 6, 2022 Hello everybody, I d like to know if someone could help me about how to validate in a simple way the software Calypso to be compliant regarding ISO 13485 Thank you Alex Link to comment https://qualityforum.zeiss.com/topic/10658-computer-system-validation-csv-calypso/ Share on other sites More sharing options...
[Ow...] Posted April 6, 2022 Share Posted April 6, 2022 Go to https://portal.zeiss.com/download-center/software and download the PTB certificate for your version of Calypso. I'm not certain that is what is needed for ISO 13485 but, it's what Zeiss uses to verify/validate the numerical accuracy of algorithm's for computing and I've used it when audited for ISO 9001. Link to comment https://qualityforum.zeiss.com/topic/10658-computer-system-validation-csv-calypso/#findComment-51410 Share on other sites More sharing options...
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