How to Start Preparing your RA/QA Team for the EUDAMED Database
Tuesday, September 22, 2020 | 10 AM CST
This webinar will have a 50 minute presentation followed by 10 to 20 minutes of Q&A.
This webinar, produced by Celegence, will provide expert guidance regarding the implementation of EUDAMED, the European Database on Medical Devices. The presentation will cover various modules, nuances of the UDI, interactions with Economic Operators, and expectations for Clinical Evaluation documentation. It will also help you understand the timeline, and identify which areas will require the support of a partner to ensure compliance.
- Explanations of various modules of EUDAMED – including the Single Registration Number module, and the UDI-DI module
- Explanation of the UDI of various Therapeutic Areas and Product Types
- Interactions necessary between legal manufacturers and their economic operators
- Required Clinical Evaluation documentation with respect to CER/CEPs, as well as SSCP and the PMCF Plans
This webinar is complimentary.
John N. Bradsher, PhD, RAC, Medical Device Regulatory Affairs & Quality Assurance Expert
John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: he has managed the program for MDR compliance at a medium-sized manufacturer of vascular medical devices, and in other assignments he has managed the development of clinical evaluation documents for a global manufacturer, BauschHealth. He comes from a background that is strong in basic science and biotechnology in addition to his mastery of regulatory and quality. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.
A Special Thanks to Our Sponsor:
For More Information, Contact:
Division Director, Life Science Programs
+1 (312) 224-1693