“My discussions will explore the implications of recently enacted medical device regulations and the evolving similarities, differences, and implementation issues with global UDI requirements.”
SANTA BARBARA, Calif. (PRWEB) April 17, 2018
USDM Life Sciences, the leading risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, announces that Jay Crowley will deliver two presentations at the MedTec Europe 2018 event in Stuttgart, Germany, April 18.
-What: “Why start now: A practical approach to kick-starting your MDR/IVDR implementation”
-When: Wednesday, April 18, 10:00 - 10:45 AM
-What: “Processes and Steps for managing UDI for the FDA, the EU MDR/IVDR, and other regulators globally”
-When: Wednesday, April 18, 16:00-16:30 PM
-Where: MedTec Europe 2018, Stuttgart, Germany
-Who: Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences
“I’m looking forward to my presentations at MedTec Europe,” said Jay Crowley, VP of UDI Services and Solutions at USDM. “My discussions will explore the implications of recently enacted medical device regulations and the evolving similarities, differences, and implementation issues with global UDI requirements.”
Recent legislation—European Medical Device and In Vitro Device Regulations—will present numerous remediation and implementation challenges as companies continue to distribute devices in the EU. Crowley will delve into strategies to best address and comply with these complex regulations. He will also highlight new requirements for “legacy” devices with a valid MDD/AIMD certificate and Class I devices with an expired certificate.
Crowley will also address many aspects of the EU introduction of a UDI system for all medical devices. While similar to the US UDI System, the EU UDI System exhibits some significant differences that will pose substantial implementation issues. Beyond the US and EU, Crowley will discuss the potential publication of UDI, or UDI-like, requirements from several other countries in the next 2-5 years.
At USDM, Jay Crowley assists medical device manufacturers to achieve regulatory compliance, while focusing on business process and technology solutions to help provide strategic advantage with UDI implementation for the MDR and IVDR. His experience in the field affords him specialized capability to thoroughly unpack the ramifications of new UDI legislation.
MedTec Europe 2018 is April 17-19 in Messe Stuttgart, Germany.
Jay will also present on the EU MDR during a live online workshop hosted by USDM on Thursday, April 26, 2018 at 11am PT / 2pm ET / 6pm GMT. Register 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 companies in the world and boasts a staff of industry leading experts in the areas of technology and compliance.