Software is a top cause of medical device recalls: Here’s what you can do

Stericycle Expert Solutions recently conducted a five-year assessment of recall trends, based on its quarterly Recall Index studies. The results show surprising missteps from medical device companies, especially where software is concerned. We asked Chris Harvey, director of recall solutions at Stericycle to answer some questions about the recall trends and offer some advice on

Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

UDI laser marking: Here’s the key to making it durable

Optimized lasers and passivation can make the difference when it comes to creating durable UDI laser markings for medical devices, according to a new long-term case study. Tuttlingen, Germany–based Add’n Solutions, worked with FOBA Laser Marking+Engraving to test the marking processes. The results found that FOBA’s short pulse fiber making lasers worked better when optimized to adapt to

FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last