Medical Device Reporting Issues Prompt Edwards Warning Letter
This article was originally published in The Gray Sheet
Executive SummaryEdwards Lifesciences failed to report within required time frames six serious adverse events linked to its annuloplasty rings and a replacement heart valve, according to a March 1 1warning letter
You may also be interested in...
New medicines under evaluation at the European Medicines Agency.
Discussions on the shape of health care have moved from “reimagining” to the next stage: building and executing on the vision. That is the thrust of EY’s NextWave Report: New Horizons 2019. Additionally, for medtechs seeking business continuum, “duality” is now a preoccupying thought.