An industry expert talks about the role communication and language play in clinical trials and regulatory compliance.
Overhaul labeling processes in order to handle any future regulatory changes, and consider adopting a joined-up, cloud-based labeling and artwork management solution.
A study looked at surgical work flow to better understand how Unique Device Identifiers are recorded.
UDI compliance can be costly, but it could also enable better customer relationships and improve patient care.
A digital labeling expert points out that adopting digital processes might have benefits for multiple areas of medical device manufacturing.
With FDA approval for MRI-conditional labeling for the Ellipse implantable cardioverter defibrillator, Abbott is quickly closing an important gap that previously existed in St. Jude’s portfolio.
A years-long initiative to add unique device identifiers to insurance claims forms continues, with supporters asking the new directors of CMS and FDA to rally behind the cause. A group of healthcare systems, payers, medical societies, and medical product companies have asked the new leaders of CMS...
Enterprise labeling systems can help medical device manufacturers manage data in some surprising ways. Enterprise labeling software solutions have been helping medical device manufacturers manage label design, printing, and more for years. But in today's data-rich environment thanks to Unique...
The Accredited Standards Committee X12 this week recommended that unique device identifiers be required on health insurance claims forms when high-risk medical devices are implanted or removed, but the healthcare industry is divided on the move.
The Office of Inspector General for Health and Human Services adds its voice to efforts to add device identifier information to health insurance claim forms.
With half of all medical device recalls since 2014 caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to labeling inspection.
In an effort to avoid any major interruptions in device access, FDA has finalized guidance that will give device manufacturers more time to take legacy FDA identification numbers off of certain device labels.