North America The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical devices. The Products A current, focal concern is...
Europe Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III....
Asia In April, China was hit by a vaccine scandal that has since resulted in a shortage of supply. Thousands of vaccine doses for children and adults were found to be improperly stored or expired. The vaccines were illegally sold for millions of dollars on the black...
North America As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
Europe The Ministry of Health of the Russian Federation is the country’s regulatory body for healthcare concerns. They recently released a change in regulation for medical devices. All Medical Device Registration Licenses issued from 1 January 2007 to 31 December 2012...
