Life Sciences
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...
Happy New Year! Holiday Schedule
Due to the impending December 31 deadline for Establishment Registration and Blanket No Change Certification submissions, we are currently processing an extremely high volume of SPL conversion orders. Accordingly, to guarantee delivery by December 31, we must receive...
Learn How You Can Monitor Medical Device Hazards and Review Industry Benchmarks to Mitigate Risks
To achieve market success and viability, medical device manufacturers are increasingly dependent upon regular market analysis, risk analysis, and post-surveillance data. There is a strong demand for standardized and expedited data collection to maintain market share...
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,...
