Life Sciences
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 intent...
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.
What to Consider for Combination Products Including both Medical Device and Drug Constituents
What are the required actions when a product includes both a medical device constituent and a drug constituent? Learn more from Reed Tech
Video: Planning for Med Device Label Changes for EU UDI
For a quick dive into the key MDR/IVDR changes and anticipated impacts to process and stakeholders, listen to this brief discussion for the Reed Tech Insights Series.
The 7 core elements of ISO 14971
Risk Management for the Medical Device Industry: What is ISO 14971? ISO 14971 is an International standard that describes a systematic approach for medical device risk management. ISO 14971 has been recognized as a consensus standard by most regulatory agencies around...
Webinar: How to Identify, Address and Remove the Risks of Labeling Product Recalls
Listen to the presentation as medical device labeling and device data experts from PRISYM ID and Reed Tech discuss the common causes and trends in recalls due to labeling issues. Learn about four real-life scenarios involving root causes of label recalls and how the...
Does UDI matter when it comes to Reimbursements?
Is your supply chain process prepared for reimbursement scenarios? Traditional Class I, II, III medical devices and even some ‘specialty’ accessories (like unique packaging mechanisms) need a product data management strategy that includes reimbursement considerations...
What is a GLN (Global Location Number)?
Global Location Number (GLN) How does the supply chain keep ‘order’ in identifying locations and functions? The identifying key to determine the ‘where’–physical/digital location and the ‘who’—a function and or legal entity is the GLN. Global Location Number...
Video: How Watchlists Streamline Research with Reed Tech Navigator for Medical Devices
How can product watchlists save time and effort when research is needed for medical device recalls, adverse event reports and other product comparisons? Watch this short video to learn how Navigator provides users with the power to quickly and accurately perform...
Reed Tech Insights – UDI and Class I Medical Devices
Reed Tech presented at the recent Pharma and Device Packaging and Labeling West Coast Conference in Burlingame, California. To see some quick insights, download the slides on Placing UDI on Class I Medical Device Labels and Reporting UDI Data to the FDA GUDID by...
