Stay updated with breaking news from Lead Reviewer. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
/PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and...
This page explains the steps being taken to reform public bodies and gives guidance for departments.
/PRNewswire/ -- MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) integrating U.S....
In our last post, we took a brief look back through history at FDA's approach to regulating medical device software and found that there is little distinction from the agency's approach to hardware devices.
FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems. We will review FDA’s digital health improvement highlights and take a quick look at AI/ML-enabled medical devices.