The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your bottom line in the coming years. Regulatory unique device identification requirements started with the US, spread to the European Union, and are now emerging in South Korea, Saudi Arabia, China, and elsewhere. In parallel, your commercial business partners are starting to revise their contracts to specify unique device identification be placed on products and be included in electronically published product catalogs.
With regulatory and business changes already in process, it is necessary for medical device manufacturers to evaluate the UDI impact to their global markets, define a strategy, and start preparing their solution. This discussion will focus on the current global unique device identification activities, the trends and timelines, and the past and expected future challenges in implementing unique device identification. Our featured speaker will also review the advantages of a central product information management solution that will better prepare you to make an informed decision in defining your unique device identification roadmap.
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner, Sr. Manager of Information Solutions in the Reed Tech Life Sciences group, 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 the areas of 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
Who Should Attend?
- Unique Device Identification Team Members
- Global Strategy Business Managers
- Regulatory Affairs/Operation Leaders
- Product Managers and Business Analysts
- Manufacturing, Operations, and Supply Chain Leaders
- Quality Leaders
- Medical Device IT Support
What You Will Learn
- The known requirements of leading regulatory and commercial unique device identification adopters
- The differences and similarities of FDA unique device identification and EU unique device identification
- The growing difficulties in managing and reporting medical device information
- The advantages of a comprehensive, global strategy for unique device identification compliance
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. ReedTech is a LexisNexis company.