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.
By the end of 2017, revenues from mHealth products will rise by 61 percent to $26 billion, according to a new analysis by Research2Guidance. But lack of final FDA guidance on mHealth apps is keeping devicemakers from realizing the full potential of this segment, the report says. App publishers surveyed for the report listed “missing regulations” as the main market barrier. Devices & Diagnostics Letter