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.
The U.S. Office of Management and Budget has approved the U.S. Food and Drug Administration’s (FDA) long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency. The rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program that could become the world’s industry standard. International Medical Device Regulatory Monitor