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The products were included in the new regulation to “introduce requirements around the manufacturing and surveillance of these previously unregulated products,” the agency said. Read More
As digital transformation sweeps through the pharmaceutical and medical device industries like a tsunami, stakeholders in those sectors are trying to figure out how to deal with the staggering changes that are likely to be left in its wake. Read More
According to the working plan, 33 NB designation applications were received as of mid-September and 22 joint assessments have been scheduled. Read More
The invisible braces have a dual layer polymer, including a soft inner tray that improves grip and a firm outer tray for improved force application. Read More
“Europe is the new hotbed for start-ups in the robotic rehabilitation field and we are proud to be the first EU company to get the certification,” said Gogoa’s CEO Carlos Fernandez. Read More