This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Life Sciences

Life Sciences

Medical Device Recalls-An Industry Snapshot

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: EU MDR-Best Practices for UDI Data & Product Labeling

Webinar: EU MDR-Best Practices for UDI Data & Product Labeling

In our next free webinar, featured speakers from Reed Tech and PRISYM ID will discuss what device companies will need to do to be EU MDR compliant. The discussion will focus on device registration, UDI data management and product labeling. Other topics include EU MDR...

Webinar Recording: Predicting Medical Device Recalls

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...

Survey Shows Most Are Continuing Preparation for EU EUDAMED

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: Prepare for EU and Other Global Regulators

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...

What to Do Now that EU EUDAMED is Delayed

What to Do Now that EU EUDAMED is Delayed

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 May 2022. Download EUDAMED Delay Fact Sheet from Reed Tech. The...

Video – US FDA GUDID Class I Reminders

Video – US FDA GUDID Class I Reminders

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? The deadline for 2020 is fast approaching.  Class I devices, and devices that have not been classified into class I, class II or class...

Webinar Recording: UDI Data Management Around the Globe

Webinar Recording: UDI Data Management Around the Globe

MedTech Digital Week hosts as Reed Tech shares their expertise on the topic of ‘Unique Device Identification (UDI) Data Management Around the Globe’.  On the agenda: UDI Introduction and Global Landscape US UDI Recap EU UDI Summary Other Regulators and...

Reed Tech Insights Series – US FDA and EU EUDAMED Comparisons

Reed Tech Insights Series – US FDA and EU EUDAMED Comparisons

Are data elements for EU EUDAMED similar to US FDA for unique device identification (UDI) submission? The short answer is, ‘not exactly.’ In this series of Reed Tech Insights, we take a deep-dive into the UDI data attributes of US and EU in specific areas,...

Drug Establishment Registration Reporting Requirements and Timelines

Drug Establishment Registration Reporting Requirements and Timelines

Registration Deadline December 31, 2019                                      What are Drug Establishment sites? Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import...

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...

Meet the Team-Christina Wagner

Meet the Team-Christina Wagner

Meet the Team at Reed Tech Christina Wagner, Account Executive, Medical Devices   Q: What aspects of your job are most motivating? A: I have always loved helping others make connections to meet their specific needs. Within this role, it has been extremely rewarding to...

Meet the Team-Maura Gouak

Meet the Team-Maura Gouak

Meet the Team at Reed Tech Maura Gouak, Sales Development Representative, Medical Devices   Q: What aspects of your job are most motivating? A: Medical device regulatory requirements for the U.S. FDA and soon, other countries, is overwhelming. Sometimes, it is...

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close