Courtesy notification of news from FDA: The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID). As a medical device manufacturer or other...
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Reed Tech Takeaways from RAPS Euro Convergence
Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech Life Sciences at the RAPS Euro Convergence conference in Amsterdam. Upon Miriam’s return, we took some time to sit down and ask her a few questions...
LexisNexis Reed Tech teams up with RegDesk, a leading regulatory information management platform
Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform, supports global medical device companies. LexisNexis Legal & Professional today announced,...
Coffee Talk with Reed Tech – EU EUDAMED Testing Update
In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and John Lorenc (Director Product Management, Medical Devices), discuss EU EUDAMED access connection issues, who has been affected, what scenarios had...
Class I UDI Inventory Exception: What You Need to Know about FDA Compliance
With the US Class I UDI enforcement quickly approaching, you may be wondering “what about older inventory”? In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without...
Vision Expo West and Eyewear Industry UDI
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on September 14th – 17th. This year's event took place at the Venetian Convention Center & Expo in Las Vegas, Nevada. We asked a few questions about her...
FDA Class I Medical Device UDI Due December 2022
Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI)...
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product...
Preparing, Managing and Monitoring Medical Device UDI
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...
Organizing and Finding Documents Easily for Medical Device Companies, Featuring Greenlight Guru
At Reed Tech Life Sciences, we know the challenges of locating and securing important documentation for both internal and external downstream users. In a recent webinar presentation, Reed Tech Alliance member, Greenlight Guru, showcased how their solution empowers...