When it comes to EU declarations of conformity, Basic UDI-DI or BUDI-DI is a critical main key for EUDAMED database records. Learn more about EUDAMED device registration, UDI submissions and BUDI-DI structures and requirements from the industry experts in the upcoming installment of Ask the Experts.
In this webinar, experts Ronald Boumans and Gary Saner will answer questions about common and unique scenarios related to BUDI-DI and how it affects medical device manufacturers.
Key Takeaways:
Learn the definition and history of BUDI-DI
Get clarity around the differences between BUDI-DI and UDI
Find out about different scenarios that affect BUDI-DI requirements.
Learn about the technical documentation required for BUDI-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
Quality Leaders
IT Support
Panelists:
Ronald Boumans, Strategic Consultant, Founder, PRRC Academy
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Ronald Boumans
LinkedIn
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
LinkedIn
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.
