SANTA BARBARA, Calif., April 17, 2019 /PRNewswire-PRWeb/ -- USDM Life Sciences (USDM) announces that Jay Crowley, Vice President of UDI Services and Solutions at USDM, will deliver a presentation on solutions for Creating a Sustainable Global UDI Compliance Strategy at the European UDI Forum on 25 April 2019.
Jay's presentation will include the following insights:
- What device manufacturers did to comply with the US FDA UDI rule and should DO again
- What device manufacturers did to comply with the US FDA UDI rule and should NEVER DO again
- How to build complaint systems, structures, and processes to manage future variations and expanded requirements beyond post market surveillance
Presentation Details:
What: Creating a Sustainable Global UDI Compliance Strategy
Where: European UDI Forum — Pullman Brussels Centre Midi Hotel — Brussels, Belgium
When: 25 April 2019 at 10:20AM
"EUDAMED database compliance requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) are coming, and medical device manufacturers need to be building their global compliance strategy now," said Jay Crowley. "Companies that successfully build a compliance strategy to future-proof their data management processes will stay ahead of any new regulatory requirements that arise."
Jay is a recognized expert in the area of UDI and 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. Most recently Jay was the Senior Advisor for Patient Safety in the FDA's Center for Devices and Radiological Health. His contributions to design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting are highly regarded.
The European UDI Forums 24-25 April 2019 in Brussels, Belgium.
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:
Navigating Global UDI Requirements
New EU Medical Device and Diagnostics (MDR / IVDR) Regulations
Contact:
Ryan Carmel
USDM Life Sciences
(805) 865-2660
rcarmel(at)usdm.com
SOURCE USDM Life Sciences
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