Ask the Experts: What to know about Basic UDI-DI Part II
Ask the Experts:
What to know about Basic UDI-DI Part II
Manufacturers of EU Medical Devices and IVDs need to create Basic UDI-DI values and include them in their technical documentation. These product grouping values are used in related documentation, e.g., certificates, declaration of conformity, summary of safety and clinical performance, and also reported to and used as critical identifiers in the EUDAMED database. Your strategy in assigning and defining the scope of your Basic UDI-DIs has far reaching impacts and therefore it is important that it is correct from inception.
Learn more about Basic UDI-DI structures, requirements, and EUDAMED UDI/device registration from industry experts in the second installment of Ask the Experts: What to Know about Basic UDI-DI. In this webinar, experts Ronald Boumans and Gary Saner will answer live audience questions about common and unique scenarios related to Basic UDI-DI and how it affects medical device manufacturers.
Hear examples of why it is very important to get the Basic UDI-DI right
Understand key concepts abut Basic UDI-DI
Get clarity around the differences between the Basic UDI-DI and UDI
Find out about different scenarios that affectthe Basic UDI-DI requirements
Learn the technical documentation required forthe Basic UDI-DI
Who does this apply to:
Global Strategy Business Managers
Regulatory Affairs/Operation Leaders
Product Managers and Business Analysts
Manufacturing, Operations, and Supply Chain Leaders
Ronald Boumans, Founder, PRRC Academy, Strategic Consultant, Boumans Regulatory Consulting
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Ronald Boumans,formerly a Senior inspector at the Dutch competent authority for medical devices, the IGJ, and a Senior Regulatory Consultant at Emergo. He now owns his own consulting company, Boumans Regulatory Consulting, and serves as founder of the PRRC Academy.
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. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
Life Sciences Solutions Driven by Accuracy and Insight 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.
Boumans Regulatory Consulting offers your team quick access to an expert that can help with global regulatory compliance. In addition, Boumans Regulatory Consulting can execute the role of the PRRC or act as a back-up PRRC. Boumans can also support you in Borderline and classification support, notified body search and selection, and mergers & acquisitions support.
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