The Challenges and Considerations for Building Your Own UDI Solution – Hard Lessons

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.

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 informative and engaging live webinar, hear some wisdom and explore all the options when it comes to UDI submissions for FDA, EU and other global regulators. The featured speakers each have 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.

Speakers

Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. With an understating of regulations, business requirements and systems, he has helped shape and implement solutions at Reed Tech for data management, validation and processing of drug labeling and medical device unique device identification content. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

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Ray Woeller, Senior Director Software Dev Group & PMO, Reed Tech

Ray Woeller oversees the day-to-day operations of the Reed Tech software development organization. Ray is a pragmatic and innovative thinker with progressive experience in the delivery of technology strategies, business-critical applications and enterprise infrastructure. He has deep-industry experience in information technology and has held major leadership positions. He has advised companies to achieve transformational success by improving the technology organization with stack and processes aligned with the value creation plan.  He has extensive background in creating high-performing teams that strengthen business and facilitate company growth and turn ideas into working solutions while providing technology roadmap assessments, and technology and organizational integration planning.

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