The Challenges and Considerations for Building Your Own UDI Solution – Hard Lessons, New Webinar Hosted by Xtalks
TORONTO (PRWEB) June 06, 2019 -- Existing and upcoming Unique Device Identification (UDI) regulatory requirements are creating challenges for medical device manufacturers. Starting in 2014, the US Food and Drug Administration (FDA) began phasing in UDI requirements for high-risk Class III devices and has set an upcoming UDI compliance date of September 2020 for Class I devices. Also, in 2020, the EU will begin enforcing UDI requirements for medical devices, and in the near future, UDI will be required in South Korea, Saudi Arabia, Australia, China and other regions.
In light of these upcoming regulatory requirements, companies may want to know:
- Is their product data management plan ready for the impacts and risks of UDI compliance in the regions they market towards?
- Has the team evaluated the feasibility of building their own UDI solution?
- Should they buy, rent or outsource the needed technology and expertise?
- What other questions should they explore when it comes to resource, maintenance, risks and budgets in planning and implementing a long-term global UDI solution?
All the complexity around UDI regulatory (and commercial) requirements create serious challenges for product data management. When considering what’s at stake, a discussion with those who have taken on the ‘build’ challenge and learned some hard lessons is a good place to start.
In this hour-long informative and engaging live webinar on Tuesday, June 25, 2019 at 11am EDT (4pm BST/UK), hear some wisdom from Reed Tech’s Senior Manager of Information Solutions Life Sciences Gary Saner, and Senior Director Software Dev Group & PMO Ray Woeller and explore all the options when it comes to UDI submissions for FDA, EU and other global regulators.
Each speaker has a long tenure in the UDI solutions environment. From the start of the first FDA UDI mandate back in 2014 to the imminent EU UDI regulations, they have experienced the highs and lows of resolving the known and unknown in UDI data management and submissions.
For more information or to register for this free event, visit The Challenges and Considerations for Building Your Own UDI Solution – Hard Lessons.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Contact:
Candice Tang
Tel: +1 (416) 977-6555 ext 400
Email: ctang(at)xtalks.com
Candice Tang, Xtalks, http://www.xtalks.com, (416) 977-6555, [email protected]
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