The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials. The elderly patients died in 2003 and 2004 after bone cement made by Synthes’ Norian subsidiary was injected into their spines, allegedly causing their blood pressure to plummet. Their families filed suit in Contra Costa [Calif.] County Superior Court on Feb. 27. Devices & Diagnostics Letter