Life Sciences
Electronic Drug Listing and Registration Guides
To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...
UDI Labeling (Unique Device Identification): Best Practices
Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA,...
Update: EUDAMED Actor Module Now Planned for December 2020
EU EUDAMED Update Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The...
NAVIGATOR for Drug Labels: Faster product label creation means faster time to market for rare-disease drug manufacturer
Katelyn Zumpino, Account Executive with the Life Sciences sales team at Reed Tech, shares a front-line perspective on the value of Reed Tech Navigator™ for Drug Labels for a rare-disease biopharmaceutical manufacturer. In working with life sciences customers, I...
UDI and 21 CFR Part 11
Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...
WEBINAR RECORDING: Updates to Health Canada’s New XML Product Monograph Launch. What you need to know and do.
Gary Saner, Sr. Manager of Information Solutions at Reed Tech Life Sciences and a subject matter expert on Drug Labeling, FDA regulations and other regulatory agencies and Jon Nolan, Associate Product Manager for Reed Tech Life Sciences Structured Product Labeling...
Your Response to the FDA Class I Medical Device UDI Delay
Update on FDA Class I UDI On July 1, 2020 the U.S. Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high quality Unique Device Identification (UDI) submissions...
Webinar Recording: Update Your Medical Device UDI Data & Labels-This Year FDA Class I | Next Year EU MDR
3:55 Webinar Recording Excerpt When you’re involved with the regulatory requirements in the medical device industry, deadlines are usually on the horizon. Join speakers from Reed Tech Life Sciences and NiceLabel® for a review of what you need to know and take...
Webinar Recording: How Medical Device Classification and Identification Impact the Device Lifecycle
4:06 Webinar recording excerpt Review this educational virtual panel discussion of ‘How Medical Device Classification and Identification Impact the Device Life Cycle’. Speakers from Reed Tech, Greenlight Guru and GMDN Agency discuss the topic and take...
Fact vs Fiction: UDI in China and Global Data Pools
Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...
WEBINAR RECORDING: Drug Pregnancy & Lactation Labeling Rule (PLLR) Best Practices to pass FDA validation
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How does a Medical Device Product Data Pool Work?
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...
Electronic Drug Registration & Listing Process (eDRL). A How-to Guide for OTC Distributors
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...
WEBINAR RECORDING: How to expedite FDA registration of your product during the pandemic
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...
Fact vs Fiction: GDSN Connection
Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction: Most global health authorities subscribe to a GDSN data pool, therefore, UDI compliance can be achieved by a standard GDSN data pool publication. Fact: One of the largest health authorities,...
Impact of Product Classification & Identifiers on Medical Device Safety & Quality Research
Author: Rachel Benway, Product Manager, Reed Tech Numerous Public Databases Abundant data is available about medical devices through the FDA including Approvals & Clearances, Adverse Events (MAUDE), Recalls, and Unique Device Identifiers (GUDID). Unfortunately,...
Expedited Assistance for Regulatory Compliance Related to COVID-19
Many organizations are stepping up to innovate and transform their operations to implement goods and services needed in the battle against COVID-19. Reed Tech stands ready to help and is making mitigation of COVID-19 a priority. We remain fully operational to assist...
Balance Medical Device Risk Analysis with Internal & External Data
Author: Rachel Benway, Product Manager Last month we held a webinar on the updates to ISO 14971 published fall of 2019 and the importance of using post-market data as part of any risk analysis process. Throughout the webinar, we performed several polls and learned...
Fighting COVID-19: Expedited FDA Product Label Approval of Hand Sanitizer and Other Products to Thwart COVID-19
The coronavirus (COVID-19) pandemic has caused disruption in the supply of alcohol-based hand sanitizers—a vital tool for hand hygiene. Traditional producers are working to increase output, and now alcohol manufacturers have an opportunity to leverage their...
Webinar Recording-Using Postmarket Data for Risk Analysis based on the Updated ISO 14971
2:27 Webinar recording excerpt How does a medical device risk become a harm? In December of 2019, ISO released a new version of their risk management regulation ISO-14971. The intent of the regulation remains unchanged but the ISO has made some changes to better...
510(k) Streamlining and Lessons Learned
Author: Erin McDermott, Account Manager Life Sciences Attending a Virtual Conference As is the rest of the world, the MDMA FDA 2020 Forum seemed to be in a place of uncertainty leading up to its scheduled occurrence last Thursday & Friday in Palo Alto, CA....
