For Reed Tech Customers:
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 UDI 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 UDI be placed on products and be included in electronically published product catalogs.
For our valued customers, this webinar will focus on answering questions you may have about global regulatory submissions, starting with EU MDR. We will also review flexible solutions for UDI data management with options for implementing a stand-alone or integrated Data Hub Model with SingleSource™ for Medical Devices.
Join medical device data experts from Reed Tech for a focused discussion on our implementation and phased plans for the EU Medical Device Regulation (MDR) UDI submission deadline of May 2020.
The SingleSource system is a Reed Tech hosted, online repository with governance and controls for data quality, data integrity and data security. This global solution can seamlessly act as a “single source of truth” allowing medical device manufacturers to confidently and efficiently distribute accurate product UDI data to multiple regulatory agencies and commercial partners throughout the world, each with different regional requirements, or it can integrate with existing PIM/MDM systems and provide the “last mile” support.
Who should attend?
Gary Saner, Senior Manager Information Solutions, Reed Tech
Gary 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.
Andrew Pfeifer, Senior Account Executive, Reed Tech
Andrew is an experienced guiding force for medical device professionals, having spent the last 5 years in UDI related applications. He specializes in understanding the complexities of product data management from a total product lifecycle point of view. He has worked with some of the world's leading medical device manufacturers on successful implementations of solutions and services from Reed Tech.