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.
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.Message Presenter
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.Message Presenter
Who Should Attend?
This webinar will be beneficial for individuals with the following or related job titles:
- IT professionals
- Software Development professionals
- Product Information Managers
- Regulatory and compliance officers
- Quality control and quality systems officers
- Data management and statistics personnel
- Manufacturing directors and supervisors
What You Will Learn
Attendees will learn about these key topics:
- The global UDI landscape – EU is just the next domino to fall in this game
- What are the challenges and considerations for building your own system?
- What does it take to build and maintain a system for the long haul?
- What are the resource and budget implications – initial and ongoing?
- What are the key risks of going with a vendor solution? Are they really risks?
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles. Our customers are located throughout the world and include the U.S. government, numerous Patent Authorities, IP-driven companies, law firms, and a wide range of pharmaceutical and medical device manufacturers. The corporate culture is driven by a commitment to excellence, innovation, and a strong dedication to our customers, employees and communities. Reed Tech is a LexisNexis company.