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Life Sciences

Life Sciences

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...

Meet the Team-Erin McDermott

Meet the Team-Erin McDermott

Meet the Team at Reed Tech Erin McDermott, Account Executive, Medical Devices   Q: What can you tell us about your current role? A: My current role at Reed Tech is a hybrid position supporting Navigator for Medical Devices across all territories. I support anyone...

How My True-Life Medical Device Story Includes UDI

How My True-Life Medical Device Story Includes UDI

Authors: Maura Gouak, Sales Development Representative & Angela Alexandrow, Marketing Manager, Life Sciences A member of our Life Sciences team, Maura Gouak, told us about her recent experiences with a medical device. In February, she was involved in a serious car...

Shedding Light on Possible New FDA Sunscreen Regulations

Shedding Light on Possible New FDA Sunscreen Regulations

With Memorial Day Weekend marking the unofficial start of summer, millions of Americans are now enjoying warmer weather and more time outdoors. As consumers restock their beach bags and picnic baskets, the Food & Drug Administration continues to take a closer look...

CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

Author: Carla Long, Account Executive, Life Sciences Congressional passage of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) established a new category of cannabis as “hemp”—that is, cannabis and cannabis derivatives with extremely low concentrations (no...

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