This article provides definitions for the regulatory terminology associated with device labeling. The Federal Food, Drug and Cosmetic Act (the Act) is the law that is applicable to medical device ...

While this paper is a quick read, it provides clarity in distinguishing between the various types of labeling as well as a ‘checklist’ of all labeling that needs to be considered when changing one ...

The European medical device industry is a third of the way into a 3-year transitional period that ... approval and commercialization of devices that are sold in the EU. Will your labeling strategy ...

PRISYM 360 is the ONLY labeling solution dedicated to Medical Device and Life Sciences. PRISYM 360 provides organizations with complete label integrity to meet the strictest compliance requirements ...

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter ...