Life Sciences
Medical Device Recalls-An Industry Snapshot
Author: Rachel Benway, Product Manager Reed Tech Since 2016, Reed Tech has been designing and curating the Navigator™ for Medical Devices database. At this point, it is a vast and rich source of medical device data. Using this database, we were able to run some...
Webinar: EU MDR-Best Practices for UDI Data & Product Labeling
In our next free webinar, featured speakers from Reed Tech and PRISYM ID will discuss what device companies will need to do to be EU MDR compliant. The discussion will focus on device registration, UDI data management and product labeling. Other topics include EU MDR...
Webinar Recording: Predicting Medical Device Recalls
Is predicting medical device recalls possible? In this presentation, we review some compelling research that indicates-yes! Did you know? We have been designing and curating an expansive database of medical device companies and products since 2016. Review an overview...
Reed Tech Selected by The Vision Council as the full-service solution for UDI
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 Council HORSHAM, PA. (PRWEB) JANUARY 07, 2020 Reed Technology and Information Services Inc. (Reed Tech™),...
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...
