New leadership often means new regulations for government, which can create uncertainty for cybersecurity teams that manage and protect vast networks of devices. Automation is one way to streamline ...
Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize ...
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
A comprehensive and forward-looking regulatory framework for emerging technologies can address integration challenges, ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
DENVER (KDVR) — Police in Colorado have arrested a suspect accused of planting incendiary devices at a Tesla dealership in Loveland. Lucy Grace Nelson, 40, was arrested on Monday just before ...