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Medical Device Product Data Management

Medical Device Product Data Management

UDI: A Guide to Device Identifiers

UK NHS eProcurement: The What, Who, Why and When

Reed Tech SingleSource™ for Medical Devices

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,...

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...

Video: EU UDI – Q&A with Gary and John

Video: EU UDI – Q&A with Gary and John

If you are looking for useful desktop references concerning EU UDI, you have come to the right place. Reed Tech recently hosted a webinar discussion that included insights on what is currently known about EUDAMED requirements. The speakers covered detailed slides on...

Reference Doc: FDA & EU UDI Data Elements List

Reference Doc: FDA & EU UDI Data Elements List

Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of...

Blog: 3 Ways to Simplify UDI and GDSN Data Management

Blog: 3 Ways to Simplify UDI and GDSN Data Management

Tracking and Tracing Medical Devices: 3 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech The challenge of tracking medical devices throughout the health care supply chain and delivery...

Video: How is BUDI-DI different from UDI-DI?

Video: How is BUDI-DI different from UDI-DI?

Basic UDI-DI or BUDI-DI has a unique history in the industry, causing some confusion with the definition. In this episode of Reed Tech Insights, our resident UDI guru, Gary Saner, walks through a comprehensive history, definition and solid examples to provide a...

White Paper: Global & EU UDI Data Management Challenges & Solutions

White Paper: Global & EU UDI Data Management Challenges & Solutions

The UDI product data submission process can be arduous without the right expertise and tools. Failures in the process can have a significant, negative impact on a medical device manufacturer’s bottom line. In light of regulatory and marketplace demands, proactive...

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