Life Sciences
510(k) and Medical Device Safety News
Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to...
Don’t Wait! Blanket No Change Product Certifications – Top 6 Process Errors
If you need to submit a Blanket No Change Certification (BNCC) for your drug products this year, be aware that validation procedures are being strongly enforced by the FDA. You may encounter unforeseen errors this year that were not detected last year and need...
Increase Your Corporate Value by Providing Product Data via GDSN
Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...
Video: Medical Device Industry Trends & Timelines
What trends are expected with Global Regulator UDI activity and anticipated timelines? Listen to a short excerpt on medical device industry trends and timelines from the recent webinar: From UDI to GDSN-Are You Ready? Questions about how to put your UDI data to...
Video: How to Efficiently Share Medical Device Product Data through GDSN
What is the Global Data Synchronization Network? The Global Data Synchronization Network (GDSN) is the electronic information highway that connects medical device manufacturers, distributors and hospital networks. It is a vital communication network designed to enable...
Webinar: From UDI to GDSN-Are You Ready?
Listen to medical device data experts from Reed Tech to learn about the benefits of putting your UDI to practical use and the importance of preparing your data now for GDSN and anticipated commercial data exchange requirements. Learn how a manufacturer can pivot from...
The Clock Is Ticking! DSCSA Serialization Requirement and Certification Deadlines
By Amy Vecchione and Gary Saner, Reed Tech As part of the FDA Drug Supply Chain Security Act’s (DSCSA) product tracing scheme, manufacturers and repackagers are required to place a unique product identifier (serialization) on each package of human prescription...
All Along the Watchlist — Product Alerts
If you monitor medical device products, that can mean waiting to receive notifications from the FDA or other entities to surface news about reported problems or recalls. With Reed Tech Navigator™ for Medical Devices, users can activate Product Alerts to receive email...
Don’t Forget: Blanket No-Change Certification – November 28 Serialization Requirement
An important notice to manufacturers and re-packagers of prescription drug products issued recently from the FDA website. You may recall that in 2017, the FDA introduced a change requiring registered drug establishments to submit a “blanket no-change...
Webinar: Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period?
Join Jon Nolan of Reed Tech to learn about annual No Change Certification submission requirements for drug product listings and what steps are needed to submit. WATCH NOW FOR: Submission requirements for FDA’s No Change Certification for drug product listings...
K2M Case Study: Tackling UDI and What Comes Next
Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people...
Webinar: From UDI to GDSN: How The Medical Device Data Landscape Keeps Evolving
Join John Lorenc from Reed Tech, Becky Aldhizer from STERIS Corporation, and Scott Brown from 1WorldSync as they discuss commercial data exchange efforts through GDSN. WATCH NOW FOR: The basic principles of GDSN and how it works How STERIS Corporation pivoted from UDI...
Don’t Forget—Medical Device Data Submission Deadlines in 2018
Beginning in September of 2014, medical device manufacturers have faced a series of data submission and maintenance requirements from the FDA as part of its Unique Device Identification (UDI) initiative. The agency phased the compliance deadlines by device class,...
Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels
Horsham, Penn. – July 9, 2018 – Reed Technology and Information Services Inc. (Reed Tech), a provider of high-quality data management and analytics solutions for the life sciences industry, announces the launch of Reed Tech Navigator™ for Drug Labels. Navigator for...
FDA Drug Listing: When You Need a Manual Override
One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents...
Webinar: FDA Drug Listing Requirements for Manufacturers & Distributors
Join Jon Nolan and Gary Saner of Reed Tech to learn about FDA requirements for electronic Drug Listing and their application to Contract Manufacturing (CMO) and Private Label Distributor (PLD) organizations. WATCH NOW FOR: Electronic Drug Listing Environment History...
Structured Product Monograph: Health Canada Plants its SPL Flag
In 2016, Health Canada announced its intention to adopt a structured format for its drug product monographs. In harmonization with international data standards, Canada selected the HL7 Structured Product Labeling (SPL) authoring standard for its product monograph...
Webinar: EU MDR’s Impact on Labeling: UDI in Europe and Other Changes
Gary Saner of Reed Tech and Mark Cusworth of PRISYM ID discuss the new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and the impact on labeling, including label formats, IFU information and symbols. WATCH NOW FOR: Label requirements...
The Continuing Evolution of UDI: Highlights from the 2018 UDI Conference (Part 2 of 2)
Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here. FDA Makes GUDID Changes to Improve Data Quality Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality...
UDI Flows Downstream: Highlights from the 2018 UDI Conference (Part 1 of 2)
At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one...
Video: Deeper Market Research with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical Devices A whole new way to conduct deeper market research with safety and quality data. Learn more at ReedTech.com/Navigator Sign up for a demo of...
