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Among other questions, the lawmakers asked what resources the agencies are using to assess the extent of the scams and what actions they are taking against those involved. Read More
Greiner Bio-One neglected to finish validation testing for the qualification of a new supplier it used in the manufacturing of its Vacuette brand blood collection tubes, the agency said. Read More
The agency received several responses, but they were deemed inadequate because they didn’t address process changes between the two heating fixtures. Read More
The agency noted in new guidance that COVID-19 and other factors are creating obstacles for labelers in meeting the UDI direct mark requirements for certain finished devices already manufactured, labeled and in inventory. Read More
“The medical technology industry would strongly encourage allowing ‘virtual audits’ when necessary and consider them as a tool to overcome challenges linked to the CE marking procedure when on-site audits cannot be performed,” MedTech Europe said. Read More
The Rover offers the high power required for trauma imaging and features a design that enables increased ground clearance and battery life needed by military operations. Read More
The device comes with preoperative planning software that streamlines implant selection prior to surgical procedures and allows the surgeon to plan positioning. Read More