Life Sciences
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...
EUDAMED Actor Module Release by MDR Date of Application
New Approach Outline for the Continued Development of EUDAMED On Friday, March 13th, the Medical Device Coordination Group (MCDG) published a new guidance document titled: ‘Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)’....
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...
Webinar Recording: Predicting Medical Device Recalls
Is predicting medical device recalls possible? In this presentation, we review some compelling research that indicates-yes! Did you know? We have been designing and curating an expansive database of medical device companies and products since 2016. Review an overview...
Reed Tech Selected by The Vision Council as the full-service solution for UDI
Reed Tech is proud to be recognized as the full-service solution for Unique Device Identification (UDI) to US FDA and other Global Regulators by The Vision Council HORSHAM, PA. (PRWEB) JANUARY 07, 2020 Reed Technology and Information Services Inc. (Reed Tech™),...
Survey Shows Most Are Continuing Preparation for EU EUDAMED
Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech Survey Results Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission’s...
Webinar Recording: Understanding EU EUDAMED, Global Requirements & GDSN
Reed Tech and 1WorldSync co-present on the topic of ‘Understanding EU EUDAMED, Global Requirements and GDSN’. This discussion takes a trip around the globe for UDI initiatives, timelines, and expected future challenges in implementing UDI (focusing on EU...
Webinar Recording: Prepare for EU and Other Global Regulators
RAPS (Regulatory Affairs Professionals Society) hosts as Reed Tech shares their expertise on the topic of ‘Prepare for EU & Other Global Regulators’. On the agenda: The known requirements of emerging regulatory channels and commercial UDI adopters...
EU EUDAMED Delayed-What to do now
Author: Gary Saner, Sr Manager Information Solutions, Reed Tech The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26...
