Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more
The National Institute of Standards and Technology (NIST) announced this week that it has issued draft cybersecurity guidance for hospitals to consider when using infusion pumps, particularly since infusion pumps are no...more