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The FDA has warned Vention Medical’s Barreal de Heredia, Costa Rica, facility over environmental controls, equipment upkeep and other quality issues. Read More
Medical devicemakers are rebutting IRS claims that a significant portion of the industry is failing to pay the new 2.3 percent medical device excise tax, resulting in tax collections that are 21 percent below expectations. Read More
The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. Read More
This past spring, officials at the Saudi Food and Drug Authority destroyed millions of dollars’ worth of expired medical devices that were seized at ports, as part of a government effort to ensure products entering the country are valid and safe. Read More