Life Sciences
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...
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...
Blog: 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...
Blog: 3 Ways to Simplify UDI and GDSN Data Management
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 Recording: 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...
Blog: 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...
