Explore our library of blogs, short videos, virtual event recordings and training topics
In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda specializes in helping medical device manufacturers with Unique Device Identification solutions for global health authorities like US FDA, EUDAMED and...
Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device Component, a Device Accessory, or a Standalone Device. A Device Component is any raw material, substance, piece, part, software, firmware, labeling, or...
What is UDI?Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model and version of that device on the market.How Do You Create the UDI?The...
HORSHAM, Pa., May 18, 2021 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a leading provider of data management and analytics solutions for the life sciences industry, is proud to be recognized by the Dental Trade Alliance (DTA),...
Are makers of eyewear products subject to Unique Device Identification (UDI) requirements for compliance with EUDAMED? Recent news would indicate the answer is ‘yes’. For those manufacturers of eyewear lenses and frames, a recently posted guidance document from the EU...
Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification (UDI) takes time and planning. But convincing the executives in the C-suite to allot the necessary...