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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.
Learn four strategies to simplify UDI and GSDN data management for medical device companies and ensure compliance
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...
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 and regulatory submission requirements.
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...
LexisNexis Reed Tech has been planning and developing connectivity for NMPA for some time. China UDI requires about fifty data attributes. About half of these attributes are already supported by Reed Tech SingleSource™ for Medical Devices. To date, preliminary case scenarios are already in the test development phase. It is anticipated that some business rules will materialize and change between now and the 2020 October UDI submission date.
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 Devices....
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.
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)...