Life Sciences
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...
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...
Webinar Recording: Health Canada’s New XML Product Monograph for Rx Drug Information. 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 will discuss the XML Product Monograph Process including: What is required What you need to do to...
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...
510(k)s Make the Medical Device World Go Round
Authors: Haley Lentz, Sales Manager & Rachel Benway, Product Manager, Reed Tech The medical device industry is constantly innovating new ways to treat patients in settings ranging from acute surgical care, to outpatient health centers and to home use. Of course,...
Complaints and MDRs and Recalls, Oh My!
Author: Rachel Benway, Product Manager, Reed Tech It was a rainy couple days in Washington, DC for the Complaints, MDRs, & Recalls Workshop hosted by AdvaMed on February 11th and 12th but that didn’t stop people from all over the world from gathering to discuss...
Health Canada’s New XML Product Monograph for Drug Information. What you need to know and do.
A quick look back In 2016, Health Canada announced its intention to adopt a structured format for its drug product information. The move would affect product monograph preparation, electronic submission, and approval processes for human prescription drugs. The...
Voluntary Adverse Event Reporting-Get Alerts
Author: Haley Lentz, Senior Sales Manager, Life Sciences Several years ago, our team met with a medical device manufacturer to review the safety and quality profile for one of their devices. During the review, the individual noticed a device problem they had not...
The Modernization of 510(k) and Ineligible Predicates
Author: Rachel Benway, Product Manager, Reed Tech The FDA has placed increased attention on the 510(k) Clearance pathway over the past couple of years which included publishing multiple press announcements from FDA Commissioner Scott Gottlieb and CDRH Director Jeff...
Key points from the Medical Device Postmarket Conference: Surveillance and Clinical
Author: Erin McDermott, Account Manager Life Sciences, Reed Tech Last week, I had the pleasure of attending the 6th Annual Medical Device Postmarket: Surveillance and Clinical Follow-Up Conference presented by Q1 Productions. This conference, or more of a workshop,...
Medical Device Recalls-An Industry Snapshot
Author: Rachel Benway, Product Manager Reed Tech Since 2016, Reed Tech has been designing and curating the Navigator™ for Medical Devices database. At this point, it is a vast and rich source of medical device data. Using this database, we were able to run some...
Webinar Recording: EU MDR-Best Practices for UDI Data & Product Labeling
In this free webinar, featured speakers from Reed Tech and PRISYM ID discuss what device companies will need to do to be EU MDR compliant. Agenda Who will benefit? This webinar will be suitable for individuals with the following or related job titles: Unique Device...
