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SANTA BARBARA, CALIFORNIA—(June 13, 2018) – USDM Life Sciences, the leading risk management, technology innovation and business process optimization firm for the life sciences and healthcare industries, announces a live wwebinar on preparing for the new EU MDR with Jay Crowley.  

What: Live Webinar - Preparing for the New EU MDR: Top 5 Things You Can (and Should!) be Doing Now

When: Thursday, June 21, 2018, 11am PT / 2pm ET / 6pm GMT

Who: Jay Crowley, VP of UDI Services and Solutions

WhereRegister Here

“I’m looking forward to this webinar, where we will discuss how you can start to prepare for the MDR,” said Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences. “2020 will come before we know it, and there are a number of steps that can be taken now to prevent headaches down the road.”  

In order to continue distributing devices in the EU after 26 May 2020, many of the new EU Medical Device Regulation’s (MDR) requirements must be fulfilled. Although some guidance and specifications are still forthcoming, there are several known remediation activities that can – and should – be started NOW. Join us to learn strategies for starting to address and comply with this complex new regulation.  

The discussion will include:    

Leveraging your current US UDI activities for the EU MDR

Updating your systems and processes so that you can continue to distribute devices with a valid MDD/AIMD certificate

Understanding the significant new requirements for most class I devices (no “grace period”)

Live Q & A session  

All companies (and their relevant economic operators) and all devices distributed in the EU must be registered in the EUDAMED database with the required data prior to May 26 2020.  

Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. He was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.  

Register for the webinar here.  

 

 

About USDM Life Sciences:

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world and boast a staff of industry leading experts in the areas of technology and compliance. USDM Life Sciences is doing business as USDM Europe GmbH in Germany.  

Ryan Carmel

USDM Life Sciences

(805) 856-2660

rcarmel@usdm.com  

Preparing for the New EU MDR: Top 5 Things You Can (and Should!) be Doing Now

Upcoming Live Workshop on Thursday, June 21 at 11am PT / 2pm ET / 6pm GMT

In order to continue distributing devices in the EU after 26 May 2020, many of the new EU Medical Device Regulation’s (MDR) requirements must be fulfilled. Although some guidance and specifications are still forthcoming, there are several known remediation activities that can – and should – be started NOW. Join us to learn strategies for starting to address and comply with this complex new regulation. 

The discussion will include:

  • Leveraging your current US UDI activities for the EU MDR
  • Updating your systems and processes so that you can continue to distribute devices with a valid MDD/AIMD certificate
  • Understanding the significant new requirements for most class I devices (no “grace period”)
  • Live Q & A session


About the Presenter:

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Jay Crowley

Vice President of Unique Device Identification Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

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