Medtronic gets FDA warning on documentation, responses, quality control in heart implant unit
As reported by Reuters, Medtronic said Wednesday it is responding to a warning letter from the FDA about procedures at the Minnesota headquarters of its heart implants division. The agency found problems with Medtronic’s procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues. The agency also cited problems with Medtronic’s quality control for suppliers.
Medtronic is the world’s largest medical device maker, and the cardiac rhythm disease management unit is its largest business. It makes surgically implanted devices for rapid, slow, and irregular heartbeats, and systems that monitor how those products are working.
Read the full article on the Reuters site.
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