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WASHINGTON, D.C. – AdvaMed® released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization…
WASHINGTON, D.C. – This week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of ethylene oxide (EtO) for medical device sterilization. The surgeons…
This white paper covers the history and evolution of quality systems and their application to medical devices.
This document provides successful practices for the development, manufacture, and use of batteries in medical device applications