Join the Texas Health CoLab for their monthly Learning Series.
In vitro diagnostic (IVD) devices usually comprises pathology tests and related instrumentation used to conduct testing on human bodily fluids or tissue samples to assist in clinical diagnosis. Regulatory and legal requirements applied to IVDs are set within the changing landscape, under guidelines similar to medical devices in the US. In contrast, in the EU, IVDs are defined and regulated separately from other medical devices under a separate directive.
In this presentation we will review a robust IVD development and regulatory process that has led to several successful regulatory pre-market authorizations.
Join us for happy hour at Scholz Garten afterwards!