MEDIcept Insights
Are Your Policy And Procedures In Place To Be Recall Ready?
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...
FDA’s Digital Health Center of Excellence: Recent Activities and Plan for the Future
The FDA's Digital Health Center of Excellence (DHCoE), founded in 2020, is a resource for both industry and the public, intending to accelerate innovation in digital health. Recently, they've been involved in several pilots and activities to promote digital health...
EU to Delay Portions of the IVDR Rollout
The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...
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...