The implications of UDI reach far beyond the FDA Rule in the United States. The European Union is planning to implement further UDI regulation in the near future and I intend to help my audience understand how it will play out
SANTA BARBARA, Calif. (PRWEB) June 05, 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 a presentation at the GS1 Connect 2018 conference in Phoenix, AZ, June 5, 2018.
- What: “UDI Around the Globe”
- When: Tuesday, June 5, 3:00-3:45 PM
- Where: GS1 Connect 2018—JW Marriott Phoenix Desert Ridge—Phoenix, Arizona
- Who: Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences
“I’m eager to discuss the status of UDI around the world at this year’s GS1 Connect event,” said Crowley, VP of UDI Services and Solutions at USDM. “The implications of UDI reach far beyond the FDA Rule in the United States. The European Union is planning to implement further UDI regulation in the near future and I intend to help my audience understand how it will play out.”
There are many new UDI and UDI-like requirements being introduced globally. All of these are intended to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities. These activities cover the total lifecycle of a device and will ultimately include long-term safety, effectiveness, and value. All of this requires manufacturers to have a level of control and visibility over their products and processes, which probably does not exist today, and may require new systems to support these activities.
This talk will outline the roadblocks to compliance as regulations are enacted, but more importantly, how to overcome them.
Jay Crowley has 27 years of experience with the FDA working with adverse event reporting, patient safety, and design control regulations to reduce the chance of human errors with medical devices. Those years in the industry allow him to aid medical device companies in their journey toward regulatory compliance, while focusing on business process optimization and technology solutions to give them the edge in UDI implementation for the MDR and IVDR.
With the help of industry professionals, USDM provides solutions that ensure your UDI compliance program will withstand the test of time while employing the most efficient practices in the industry.
GS1 Connect 2018 is June 5-7 in Phoenix, Arizona.
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. USDM Life Sciences is doing business as USDM Europe GmbH in Germany.