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.
Anti-fraud investigators may soon be taking a closer look at device clinical trials in an attempt to ensure that the safety and performance of devices reaching the market are supported by sound data, a government lawyer says. “I’m not sure research is fair and accurate, that negative studies are not being suppressed or that statistical games are not being played” to support the clearance of new devices, said Susan Winkler, chief of the healthcare fraud unit in the U.S. Attorney’s Office in the District of Massachusetts. Devices & Diagnostics Letter