Life Sciences
Survey Shows Most Are Continuing Preparation for EU EUDAMED
Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech Survey Results Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission’s...
Webinar Recording: Understanding EU EUDAMED, Global Requirements & GDSN
Reed Tech and 1WorldSync co-present on the topic of ‘Understanding EU EUDAMED, Global Requirements and GDSN’. This discussion takes a trip around the globe for UDI initiatives, timelines, and expected future challenges in implementing UDI (focusing on EU...
Webinar Recording: Prepare for EU and Other Global Regulators
RAPS (Regulatory Affairs Professionals Society) hosts as Reed Tech shares their expertise on the topic of ‘Prepare for EU & Other Global Regulators’. On the agenda: The known requirements of emerging regulatory channels and commercial UDI adopters...
What to Do Now that EU EUDAMED is Delayed
The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26 May 2022. Download EUDAMED Delay Fact Sheet from Reed Tech. The...
CBD isn’t a drug. Or is it? Planning for the impending FDA Cannabis regulations. Webinar Recording
3-Minute Webinar Preview We discuss: • How to navigate the current state of the CBD regulatory environment • Given what we know today, what does tomorrow look like • Ways to prepare for the impact of the FDA’s ultimate ruling and...
Video – US FDA GUDID Class I Reminders
What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? The deadline for 2020 is fast approaching. Class I devices, and devices that have not been classified into class I, class II or class...
Webinar Recording: UDI Data Management Around the Globe
MedTech Digital Week hosts as Reed Tech shares their expertise on the topic of ‘Unique Device Identification (UDI) Data Management Around the Globe’. On the agenda: UDI Introduction and Global Landscape US UDI Recap EU UDI Summary Other Regulators and...
Reed Tech Insights Series – US FDA and EU EUDAMED Comparisons
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,...
FDA Announces ‘Deep Clean’ of Drug Registration Database. Don’t be Thrown Out!
When cleaning out closets at home, organization experts recommend tossing or donating anything you haven’t worn in the past year. Last month, the U.S. Food and Drug Administration (FDA) announced a major effort akin to cleaning out its “closets” – in this case, its...
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...
