WALDWICK, N.J.--(BUSINESS WIRE)--NextPhase Medical Devices LLC, a leading provider of electronic manufacturing services (EMS) and single-use disposable devices to leading medical device OEMs, recently ...
Kidd & Co-backed NexPhase Medical Devices has acquired Proven Process Medical Devices. The deal expands the platform’s expertise in R&D, engineering, design and manufacturing of FDA Class II and III ...
Researchers are rolling out a new manufacturing process and chip design for silicon carbide (SiC) power devices, which can be used to more efficiently regulate power in technologies that use ...
Nearly three-quarters of medical device recalls that could have caused injury or death from 2005-2009 went through the 510(k) pre-market notification process at the Food & Drug Administration, ...
No matter your perception of the FDA's product approval process right now, Jeffrey Shuren argues that regulators have improved the complex system, and that the process is already getting better for ...
Eight serious loopholes and cracks in the U.S. Food and Drug Administration's approval process allow potentially unsafe, ineffective yet high-risk machines and materials to be approved for use on ...
Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to two new studies. One study found many U.S. Food ...
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