As we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor and platform. As such, here is a detailed analysis that highlights the tangible benefits of opting for a single, global end-to-end solution platform, compared to managing multiple vendor platforms.
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Updated Survey Shows Most Are Continuing Preparation for EU EUDAMED
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR)? Many are trying to figure out their response to the European Commission's notice that the EUDAMED launch was...
China NMPA UDI and Device Registration Basics
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...
Saudi Arabia (SFDA) Unique Device Identification Update for Med Device Manufacturers
Background Saudi Food and Drug Authority (SFDA) issued final “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” (MDS-G34) (MDS-G34 at HIBCC) in April 2019. The guidance published an update in December 2019 and a third update released...
Fact vs Fiction: UDI in China and Global Data Pools
Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...
UDI Implementation Tips and GDSN Data Management
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech Tracking medical devices throughout the healthcare supply chain and delivery system has proven...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices Supporting UDI Requirements around the Globe
HORSHAM, Pa., March 25, 2019 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech), a leader in data management and analytic services and solutions for the Life Sciences industry, announces the launch of Reed Tech SingleSource™ for Medical...
UDI Data Security: Why it should be important to you
Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio. Confidentiality: Not all data you submit to FDA as part of a UDI...
4 Questions to Ask Before Choosing a UDI Issuing Agency
As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI)...