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My experience with evolving global UDI requirements will allow me to speak about the journey to achieve regulatory compliance in the US, EU, and beyond
SANTA BARBARA, Calif. (PRWEB) April 24, 2018
USDM Life Sciences, the leading risk management, technological innovation and business processes optimization firm for the life sciences industry, announces Jay Crowley will give three presentations at the UDI Conference in Baltimore, MD, April 24-25, 2018.
Presentations
Tuesday, April 24:
-9:50-10:35am: Global UDI-Related Activity – Update on EU UDI System
The EU UDI System specifically (and prospectively) incorporates UDI into various new company and product registration systems and processes. The new regulations also impose obligations for the verification and use of UDI by importers, distributors, authorized representatives and, for certain device types, healthcare providers. The EU UDI System, though similar to the US UDI System, has some significant differences – and will face many of the same implementation issues as have occurred in the US. At the same time, there are new “commercial” or “payor” UDI-like requirements, such as those from the UK National Health System (NHS), that are beginning to develop.
-10:45-11:30am: Global UDI-Related Activity – The EU MDR & IVDR Regulations: Effective Tactics & Strategies for Implementation
The timeline for manufacturers that want to continue to sell their devices in Europe has been defined by the EU MDR & IVDR Regulations. This session will provide critical information and guidance to help you prepare to meet the timelines, expose you to a philosophical and strategic approach to efficiently manage your devices from a global vantage point, provide tactics you must consider to stay in regulatory and commercial compliance, and provide details on the technical components.
Wednesday, April 25:
-4:00-5:00pm: Think Globally: Act Locally: UDI Compliance at the Global Level
For many manufacturers, UDI compliance in the U.S. was handled with a singular focus on meeting the regulatory requirements of the FDA regulation. Now that the European Commission has issued the Medical Device and IVD regulation, and other countries have issued their draft UDI regulations, global manufacturers need to develop sustainable systems and processes to meet multiple regulations across multiple markets. A panel of medical device manufacturers will share how their organizations are expanding their UDI compliance programs to coordinate cross-functional activities and scale best practices on a global level.
“I’m excited to present on and facilitate important discussions around the UDI requirements and the recently published EU MDR and IVDR at the UDI Conference this week,” said Crowley. “My experience with evolving global UDI requirements will allow me to speak about the journey to achieve regulatory compliance in the US, EU, and beyond.”
At USDM Life Sciences, Jay Crowley assists medical device manufacturers to achieve regulatory compliance, while focusing on business process and technology solutions to give them the edge with UDI implementation for the MDR and IVDR.
Prior to joining USDM, Crowley was the Senior Advisor for Patient Safety for the FDA’s Center for Devices and Radiological Health. He held positions in the FDA for over 27 years, including work with design control regulations to mitigate human error with medical devices, patient safety and adverse event reporting. More recently, he developed the framework and authored key requirements for the FDA’s UDI system. Helping companies achieve regulatory compliance is at the crux of USDM’s Compliance as a Service Program. It leverages cutting-edge technology to deeply enhance life sciences companies’ ability to make more prudent business decisions and transform their compliance, quality, and IT operations.
USDM Life Sciences is a sponsor and exhibitor at the UDI Conference 2018, and will host a reception after the conference on April 24. RSVP here and stop by our booth, #2.
The UDI Conference 2018 is April 24-25 in Baltimore, MD.
Crowley will host a webinar on Thursday, April 26 at 11am PT/2pm ET on The New EU Medical Device Regulation (MDR): A Project Implementation Approach. 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 technology companies in the world and boasts a staff of industry leading experts in the areas of technology and compliance.