Medical Device Regulatory Changes in the Post-Brexit UK
If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...
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...
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