Life Sciences
Protected: FDA Announces ‘Deep Clean’ of Drug Registration Database. Don’t be Thrown Out!
Drug Establishment Registration Reporting Requirements and Timelines
Registration Deadline December 31, 2019 What are Drug Establishment sites? Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import...
Webinar Recording: Registering EU Medical Devices & Reporting UDI Info to EUDAMED
Greenlight Guru hosts as Reed Tech shares their expertise on the topic of ‘Registering EU Medical Devices and Reporting UDI info to EUDAMED’. A short excerpt: In this 60-minute webinar, you’ll learn: How and when to register EU medical devices and...
Reed Tech® and 1WorldSync™ to Provide Connection to European Union Database on Medical Devices (EUDAMED)
Expanded alliance to include a full-service solution including Unique Device Identifier (UDI) submission to EUDAMED Horsham, Penn. – September 10, 2019 – Reed Technology and Information Services Inc. (Reed Tech), a leading provider of data management and analytics...
A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?
Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...
Meet the Team-Christina Wagner
Meet the Team at Reed Tech Christina Wagner, Account Executive, Medical Devices Q: What aspects of your job are most motivating? A: I have always loved helping others make connections to meet their specific needs. Within this role, it has been extremely rewarding to...
White Paper: What Are the EU MDR Timelines for Device Registration in EUDAMED?
What to Know about Device Registration Timing in the EU Medical Device Regulation Medical device manufacturers can start registering products in the EU EUDAMED database as of May 26, 2020, the Date of Application (DoA) for the EU Medical Device Regulation (MDR). In...
Webinar Recording: How to bring your 510(k) Research into the 21st Century
Is your team maximizing efficiency for 510(k) predicate search? In this short and informative presentation, hear about recent FDA statements concerning medical device predicates and learn key takeaways for improving search efficiency. The presenters will review the...
Meet the Team-Maura Gouak
Meet the Team at Reed Tech Maura Gouak, Sales Development Representative, Medical Devices Q: What aspects of your job are most motivating? A: Medical device regulatory requirements for the U.S. FDA and soon, other countries, is overwhelming. Sometimes, it is...
Meet the Team-Erin McDermott
Meet the Team at Reed Tech Erin McDermott, Account Executive, Medical Devices Q: What can you tell us about your current role? A: My current role at Reed Tech is a hybrid position supporting Navigator for Medical Devices across all territories. I support anyone...
How My True-Life Medical Device Story Includes UDI
Authors: Maura Gouak, Sales Development Representative & Angela Alexandrow, Marketing Manager, Life Sciences A member of our Life Sciences team, Maura Gouak, told us about her recent experiences with a medical device. In February, she was involved in a serious car...
Shedding Light on Possible New FDA Sunscreen Regulations
With Memorial Day Weekend marking the unofficial start of summer, millions of Americans are now enjoying warmer weather and more time outdoors. As consumers restock their beach bags and picnic baskets, the Food & Drug Administration continues to take a closer look...
CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.
Author: Carla Long, Account Executive, Life Sciences Congressional passage of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) established a new category of cannabis as “hemp”—that is, cannabis and cannabis derivatives with extremely low concentrations (no...
Webinar Recording: Challenges and Considerations for Building Your Own UDI Solution
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 discussion...
Meet the Team-Patti Shragher
Meet the Team at Reed Tech Patti Shragher, Account Executive, Medical Devices Q: What aspects of your job are most motivating? A: Our customers are under tremendous compliance pressure. With the complexity of global regulatory requirements, the key to success is...
Meet the Team-Michael Cathcart
Meet the Team at Reed Tech Michael Cathcart, Account Executive, Medical Devices Q: What aspects of your job are most motivating? A: My favorite part of working with products at Reed Tech is the way they are able to improve the lives and work flow process for our...
Meet the Team-Haley Lentz
Meet the Team at Reed Tech Haley Lentz, Senior Sales Manager (Medical Devices and Pharma) Q: What aspects of your job are most motivating? A: For me, it’s so motivating to see our dreams become a reality here at Reed Tech. For example, when I started in 2013, we...
Meet the Team-Connor McNelis
Meet the Team at Reed Tech Connor McNelis, Sales Development Representative, Medical Devices Q: What is your current role at Reed Tech? A: As a Sales Development Representative, I set appointments and connect customers and prospects with Account Executives and...
Meet the Team-Andrew Pfeifer
Meet the Team at Reed Tech Andrew Pfeifer, Senior Account Executive, Medical Devices Q: What aspects of your job are most motivating? A: In my role, it is critical to effectively communicate to prospects how Reed Tech can provide value to their organization....
Video: EU UDI – Q&A with Gary and John
If you are looking for useful desktop references concerning EU UDI, you have come to the right place. Reed Tech recently hosted a webinar discussion that included insights on what is currently known about EUDAMED requirements. The speakers covered detailed slides on...
Reference Doc: FDA & EU UDI Data Elements List
Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of...
