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.

Webinar: Harmonizing your EU MDR Efforts with FDA UDI


Webinar: Harmonizing your EU MDR Efforts with FDA UDI

|

Where am I - content-blog-article.php

Gary Saner and John Lorenc of Reed Tech discuss UDI requirements in the EU and how device companies can align their EU compliance efforts with existing FDA UDI programs. WATCH NOW FOR: EU MDR / IVDR Overview EU UDI Requirements and Comparison to FDA UDI Global Data Management Approach Q&A Please complete the form to […]

FDA is Sharpening its Focus on UDI Data Quality

|

Where am I - content-blog-article.php

In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira Konduri reminded medical device industry members to avoid common data quality errors […]

A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync

|

Where am I - content-blog-article.php

Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission mandate. Others are commercial, such as hospital networks needing access to device product data electronically through the Global Data Synchronization Network […]

Webinar: UDI and the EU MDR: What You Need to Know

|

Where am I - content-blog-article.php

In this webinar, you’ll get an overview of the requirements for the upcoming Unique Device Identification (UDI) initiative in the EU from Reed Tech and PRISYM ID team members. Presenters Chris Lentz, Gary Saner and Phil Dray will address the following: EU MDR / IVDR Overview EU UDI Requirements FDA UDI Lessons Learned UDI Data […]

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

|

Where am I - content-blog-article.php

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite different in many respects. In this post, we will give you a quick summary […]

Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

|

Where am I - content-blog-article.php

As you probably know by now, FDA recently announced it would extend the Class I UDI compliance date for labeling and GUDID submissions by two years to September 24, 2020. In this post, we will take a look at why FDA chose to take this step and how Class I labelers should view their extended […]