The upcoming mandatory application of EUDAMED has created uncertainty for many MedTech organizations striving to be compliant ahead of the January 2026 target date. Compared to previous EU regulations, universal device identification (UDI) requirements under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) are significantly more complex and far-reaching.
Now is the time to proactively plan your UDI data collection, management, and transmission strategy to ensure EUDAMED compliance. As regulatory bodies increasingly evaluate and implement UDI programs for medical devices, having a unified and scalable global UDI strategy is no longer optional — it’s essential for sustained compliance and operational efficiency. Delaying action risks non-compliance that could result in audit findings, financial penalties, time-to-market delays, and the potential removal of life-changing products from the market.
In this webcast, we will demystify EUDAMED’s UDI requirements and offer actionable insights to help MedTech enterprises craft a comprehensive UDI strategy to drive compliance to current and future UDI requirements.
Key topics include:
- Comparing GUDID and EUDAMED UDI requirements
- Steps to help your team prepare for UDI submission to EUDAMED -Exploring UDI management and submission options
- Leveraging EUDAMED as an opportunity to assemble a global UDI strategy
Join us to navigate these challenges with confidence and position your organization for a timely, efficient, and effective UDI program.
MedTech regulatory affairs professionals, IT professionals responsible for UDI management, and supply chain professionals responsible for UDI management.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
Adam Price
Director of Regulatory and Technical Programs, Rimsys
Adam Price has nearly 20 years of medical device industry experience as a quality assurance and regulatory affairs professional. As Director of Technical Programs at Rimsys, Adam is responsible for the strategy, development, and implementation of all regulatory and technical programs supporting digital transformation of the Medtech industry with the Rimsys platform. Prior to joining Rimsys, Adam was the Head of Post Market Surveillance & Service Quality at Philips Healthcare. While at Philips, he focused on the development of post-market strategies and solutions to meet the changing regulatory and technical demands of the global market. Adam holds a Bachelor of Science in Mechanical Engineering and an MBA from the University of Pittsburgh.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
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