Life Sciences
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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Electronic Drug Registration & Listing Process (eDRL). A How-to Guide for Prescription Drug 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...
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...
Electronic Drug Registration & Listing Process (eDRL). A How-to Guide for Contract Manufacturing Organizations
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...
Update: EUDAMED Actor Module Delayed to 2021 March
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...
BLOG: FDA’s Mandatory Pregnancy and Lactation Labeling Rule (PLLR) Implementation: Taking the Final ‘Baby’ Steps
WEBINAR: Join us Thursday, May 14, 2020 at 11:00 am ET for our live webinar “FDA’s Pregnancy and Lactation Labeling Rule. Best practices to easily revise, submit and pass FDA validation of your label. Here’s more information...
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....
COVID-19 Resources
As the impact of the novel coronavirus virus (COVID-19) unfolds, all of us are being challenged with adapting to new ways of working and living. We are all adjusting to social distancing, remote workplaces and restricted travel. Like many other businesses around the...
Global UDI Data Management-5 Best Practices
For Unique Device Identification (UDI) data management, there are some basics that medical device manufacturers should always keep top of mind. Here’s a 3 minute run-down of Five Best Practices for Global UDI Data Management. For more information, see the...
