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.
A durable medical equipment provider pleaded guilty Nov. 21 to one count of healthcare fraud in the U.S. District Court for the Southern District of Florida in a scheme the Justice Department says defrauded Medicare of more than $11 million. Read More
Devicemakers attempting to comply with the Physician Payment Sunshine Act do not need to report repairs or training provided under warranty or the names of third parties, such as contractors, that indirectly provide a research payment to a doctor or other entity covered under the law, according to the Centers for Medicare & Medicaid Services. Read More
The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More