Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these ...
Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...
Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.) have proposed legislation designed to improve post-market surveillance of medical devices to ensure patient safety ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and ...
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