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In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for Legacy Medical Devices to be placed on the EU market. Here is a quick summary of recently posted information about the reasoning behind this decision...
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices, as prescribed in Article 18 of Regulation (EU) 2017/745 on medical devices. The requirement’s purpose is to give patients easy access to important...
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...
Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions. It was great to...
Reed Tech is proud to be recognized as the full-service solution for Unique Device Identification (UDI) to US FDA and other Global Regulators by The Vision CouncilHORSHAM, PA. (PRWEB) JANUARY 07, 2020 Reed Technology and Information Services Inc. (Reed Tech™),...
Are data elements for EU EUDAMED similar to US FDA for unique device identification (UDI) submission? The short answer is, 'not exactly.' In this series of Reed Tech Insights, we take a deep-dive into the UDI data attributes of US and EU in specific areas, noting the...
Is your team evaluating UDI regulatory submissions for EU and other regions? All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a...
Patti Shragher Account Executive, Reed Tech Life SciencesPatti enjoys solving problems with technology and takes pride in strategic challenges. She consults with customers and prospects all over the globe on Reed Tech solutions for regulatory compliance, product data...
Andrew Pfeifer Senior Account Executive, Reed Tech Life SciencesAndrew is an experienced guiding force for medical device professionals, having spent the last 5 years in UDI related applications. He specializes in understanding the complexities of product data...
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...