Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
Date: June 18th 2024, Online
Duration: 4 hours | 7:30 – 11:30 AM (EDT), 1:30 PM – 5:30 PM (CEST)
About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer and an experienced quality and regulatory affairs consultant with 11+ years of expertise in regulated industries. Besides leading the Digital Health team, he stands ready to guide organizations through the complexities of quality and regulatory affairs, ensuring excellence in the evolving landscape of medical devices globally. Koushik is an ASQ-certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.
Training Objectives:
- Understanding EUDAMED and its functional specifications
- Interpret EUDAMED data structures, requirements and business rules
- Impact of EUDAMED on QMS of economic operator
Training Content:
- Introduction to EUDAMED
- EUDAMED readiness and time constraints
- Actor registration module
- User roles and hierarchy
- Data required for actor registration
- Obtaining SRN for economic operators (EU and non-EU) – EUDAMED Input screens
- Device and UDI registration module
- Data required for device registration
- Data exchange options
- Introduction to vigilance & post-market surveillance module
- EUDAMED impact on QMS
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend:
- Quality / Regulatory Affairs Manager
- Persons responsible for regulatory affairs and quality management
- Manufacturers, authorized representatives, importers, and sponsors
- Management, and anyone interested in EUDAMED
Prerequisite:
An understanding of EU MDR and IVDR requirements is essential.
Price:
EUR 415 incl. course material and certificate