1.0MedSysCon Medizintechnik GmbHhttps://www.medsyscon.com/en/m3dsysconhttps://www.medsyscon.com/en/author/m3dsyscon/The FDA & EU IVDR Regulatory Frameworks For IVD SaMD - MedSysCon Medizintechnik GmbHrich600338<blockquote class="wp-embedded-content" data-secret="1B72nrWkaZ"><a href="https://www.medsyscon.com/en/blog-ivd-samd/">The FDA & EU IVDR Regulatory Frameworks For IVD SaMD</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.medsyscon.com/en/blog-ivd-samd/embed/#?secret=1B72nrWkaZ" width="600" height="338" title="“The FDA & EU IVDR Regulatory Frameworks For IVD SaMD” — MedSysCon Medizintechnik GmbH" data-secret="1B72nrWkaZ" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script>
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https://www.medsyscon.com/wp-content/uploads/2023/01/pic.jpg700435Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, ...