A new international database that identifies measurement procedures and materials has debuted to help U.S. makers of in-vitro diagnostic (IVD) medical devices comply their product designs with European Union requirements. The database contains about 100 reference measurement procedures, including 30 developed and maintained by the National Institute of Standards and Technology (NIST), and lists 96 approved reference materials, 72 of which originate from NIST sources. The U.S. IVD industry shares more than 60 percent of the EU market, which recently issued new regulations on the sale of IVD devices, such as those used to measure blood levels of glucose and cholesterol. For more information, go to http://rbi.ims.ca/3849-536.
Digital healthcare devices and wearable electronic products need to be thoroughly tested, lest they live short, ignominious lives, an expert will tell attendees at UBM’s upcoming Designers of Things conference in San Jose, Calif.
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