Life Sciences
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...
Meet the Team-Reed Tech Life Sciences
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-Reed Tech Life Sciences
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...
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...
Webinar Recording: New Innovations Simplifies Your Drug Label Research
Research and compare the most up-to-date drug label information in just a few clicks This demonstration of Reed Tech Navigator™ for Drug Labels shows how new product enhancements can help: Bolster your competitive intelligence with more detailed insights and...
Reed Tech Navigator™ for Medical Devices now includes searchable De Novos and Biologic PDFs
Navigator recently updated several functions to create even more efficiencies for users. Current and new subscribers will see these new enhancements immediately. Clearance Search510(k) Search has been changed to Clearance Search and now includes De Novos and Biologic...
3 Ways to Simplify UDI and GDSN Data Managment
Tracking and Tracing Medical Devices: 3 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech The challenge of tracking medical devices throughout the health care supply chain and delivery...
Reference Checklist: FDA Medical Device UDI Regulation Records, Reports, SOPs
The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a UDI placed on their product and package labels. Of equal importance, the FDA UDI regulation also requires manufactures to report medical device...
Video: How is BUDI-DI different from UDI-DI?
Basic UDI-DI or BUDI-DI has a unique history in the industry, causing some confusion with the definition. In this episode of Reed Tech Insights, our resident UDI guru, Gary Saner, walks through a comprehensive history, definition and solid examples to provide a...
Webinar replay: Navigator for Medical Devices – An easier way to do research
If you routinely access FDA databases, you know it can become time-consuming to pin-point exactly what you are looking for. In this webinar (originally recorded December 11, 2018 and co-hosted with Joe Hage at Medical Devices Group), you will see how Reed Tech has...
NHS England Extends eProcurement Deadline for In Vitro Diagnostic Devices: Q&A with Gary Saner
In December 2018, the National Health Service (NHS) England announced an extension to its eProcurement deadline for in-vitro diagnostic devices. Instead of being required to comply by September 2019, manufacturers now have until September 2021. I caught up with Gary...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices Supporting UDI Requirements around the Globe
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...
Video: What if you had a window into FDA Clearances for improved regulatory intelligence & 510(k) prep?
Want to save time doing research for 510(k) prep? See how searching for FDA Clearances for 510(k) prep can be accomplished quickly in this brief, 3 min video. Within just a few clicks, you can find new predicates for a specific or similar device or research clearances...
White Paper: Global & EU UDI Data Management Challenges & Solutions
The UDI product data submission process can be arduous without the right expertise and tools. Failures in the process can have a significant, negative impact on a medical device manufacturer’s bottom line. In light of regulatory and marketplace demands, proactive...
Did you know? Navigator for Medical Devices has made 65,000 510(k) PDFs searchable by intended use, indications for use, and device description
What is a 510(k)? In order to market a medical device, manufacturers must comply with the 510(k) section of the Food, Drug and Cosmetic Act.* This requirement states that device manufacturers must register and notify the FDA minimally 90 days in advance of their...
Webinar exclusive for Reed Tech Customers: Losing sleep over EU UDI? No worries, Reed Tech has you covered
Why is UDI strategy so important? The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your bottom line in the coming years....
Video: What if you had a window into Medical Device Safety & Quality data?
When it comes to information at your fingertips, look into Navigator and see how efficient you can be. Predicates and successors to 510(k)s, guidance documents, product comparisons, industry benchmarking; it’s all here. Thanks for populating this form to view the...
Webinar: Medical Device Unique Device Identification Challenges & Solutions
Medical device manufacturers will earn about the known requirements of leading regulatory and commercial UDI adopters
EU UDI-5 Things to Know for Pre-Planning
Reed Tech is prepared to help you build your process step-by-step as we prepare for the EU initiative throughout 2019, anticipating May 2020.
