Latest / Medical Device made Easy Podcast
Validation of Quality Software in Medical Devices
https://youtu.be/wQvuFyROLv8
Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software? The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software.
Who is Christophe Girardey?
Christophe…
The skinny
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