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Life Sciences

Life Sciences

Webinar: Harmonizing your EU MDR Efforts with FDA UDI

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...

FDA is Sharpening its Focus on UDI Data Quality

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...

Webinar: FDA Expectations for Biologic Lot Distribution Reporting

Watch our On-Demand WebinarJoin our mailing list to receive the latest news and updates from our team. WATCH NOW Thank You! David Wilson of Reed Tech discusses FDA requirements for Biologic Lot Distribution Reports (LDR) and what industry has learned three years since...

Webinar: NHS eProcurement Requirements in 2018

Gary Saner of Reed Tech discusses of what medical device companies need to do in 2018 to comply with the National Health Service eProcurement requirements and how affected medical device labelers can meet the deadline. WATCH NOW TO LEARN: UK NHS eProcurement...

Webinar: FDA’s No Change Certification for Drug Products

In this webinar, you’ll get an overview of the requirements for FDA’s new Blanket No Change Certification submission type for drug product listings. Presenter Jon Nolan will address the following: What’s Changing Requirements and Timelines Questions...

FDA’s New Drug Product Listing Blanket No-Change Certification

As part of the 2016 Final Rule on Electronic Drug Listing, FDA introduced important new changes that affect all human drug product labelers and manufacturers. Beginning in 2017, every existing human drug product listing must be either 1) updated during the course of...

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

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 /...

Webinar: FDA Annual Reporting Period for Drug Products

In this webinar, you’ll get an overview of the FDA’s requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new...

NHS eProcurement Q&A

Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to...