Jay Crowley to Present Challenges with EU MDR and IVDR Compliance

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Medical device manufacturers distributing products in Europe have less than a year to comply with the requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).

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“EUDAMED database compliance requirements under the EU MDR and IVDR are only one year away and medical device companies need a well-defined strategy to create a sustainable compliance plan” said Crowley.

USDM Life Sciences (USDM) announces that Jay Crowley, Vice President of Unique Device Identification Services and Solutions, will deliver a detailed webinar addressing challenges with the upcoming EU MDR IVDR regulations.

Jay is a recognized expert in the area of UDI and has held a variety of positions over his 26 years at the FDA, including developing the framework and authoring key requirements for the FDA’s UDI system. Prior to USDM, Jay was a Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. He currently focuses on providing business process, technology and compliance solutions for the regulated life sciences industry at USDM.

“Challenges with EU MDR and IVDR Compliance”
Thursday, August 1 at 11am PT / 2pm ET

Medical device manufacturers distributing products in Europe have less than a year to comply with the European Medical Device Regulation. To complicate matters, the requirement includes products already being distributed. For many manufacturers, there is still some uncertainty about what exactly needs to be done to comply and what data attributes need to be submitted to the EUDAMED. And, with more countries planning for their own unique device identification requirements, the challenges aren’t going away anytime soon. During this webinar, you will learn what steps you can take now to more easily comply with upcoming deadlines and future regulations.

The presentation will include the following insights:

  • Challenges medical device manufacturers are facing as they tackle EU MDR and IVDR compliance
  • Latest information on the technical specifications for EUDAMED
  • Strategies for dealing with future global UDI regulations
  • Timeline for future UDI related regulations
  • Live Q & A

“EUDAMED database compliance requirements under the EU MDR and IVDR are only one year away, and medical device companies need a well-defined strategy to create a sustainable compliance plan,” said Crowley.

To register for this webinar, click here

If you are unable to attend, you can watch the on-demand webinar here

About USDM Life Sciences:
USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM Life Sciences focuses exclusively on the regulated biotechnology, pharmaceutical, and medical device industries and is a compliance partner with the world’s top technology software developers. For more information, visit http://www.usdm.com

Additional Resources:
Will Your Company Be Ready for the Next Regulatory UDI Database?
The Evolving Global Medical Device Data Imperative

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Ryan Carmel
USDM Life Sciences
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