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Supply Chain Woes: COVID and Medical Device Manufacturing

The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving. Medical device manufacturing is just one of the many industrial...

Cautionary Tale: SpineFrontier, consulting fees, and kickbacks

The CEO and CFO of SpineFrontier, a Malden, MA-based spinal device manufacturer, were recently indicted in connection with a kickback scheme to bribe surgeons to use their products in exchange for “consulting fees,” according to a statement released by US Attorney for...

The Latest Updates to FDA’s COVID EUA’s

The COVID-19 pandemic has made obscure regulatory procedures big news across the globe. Chief among these is the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority, the expedited pathway through which COVID-19 vaccines were authorized....

Speaker Program Fraud: What You Need to Know to Protect Yourself

The healthcare industry can be full of tempting offers, many perfectly legal, though there are some that are not. To make matters more difficult, illegal ones can appear above-board and acceptable when, in fact, some aspects of them pose a significant legal risk to...

Artificial Intelligence and Medical Devices

Growing numbers of medical devices are using artificial intelligence and its associated technology—machine learning—to diagnose patients more precisely and treat them more effectively. Although many devices have already been cleared by the FDA, many regulatory...

MDR Transition: What does it mean for your company?

Talk about the fundamental changes coming to European medical device regulation has been buzzing through the industry for the past several years. Medical device firms across the globe have been preparing themselves for changes to their regulatory compliance strategies...