AI: The Murky Regulatory Outlook . . . and What’s Next
This article discusses artificial intelligence and how state, federal and international approaches and regulations are taking ...
Med Device Online20h
Mastering FDA Inspections: The Prep Work For Regulatory Success
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
Tiziana Life Sciences Announces Agreement for Product Development Services with Renaissance Lakewood, LLC
Ivor Elrifi, CEO of Tiziana Life Sciences, commented, “Partnering with Renaissance is a significant milestone in our mission to bring intranasal foralumab to patients in need. Their proven track ...
Circuit5h
Federal Electronics’ Cranston Facility Achieves ISO 13485 Recertification for High- Quality Medical Electronics Manufacturing
ISO 13485 is an internationally recognized quality management system standard for medical device manufacturers, ensuring that organizations can consistently meet regulatory and customer requirements ...
MassDevice6h
FDA says Boston Scientific Accolade pacemaker recall is serious
The FDA today issued a notice labeling the recall of Boston Scientific Accolade pacemaker devices serious as it may cause ...