RAPS members, join us in Regulatory Exchange, where Rimsys regulatory experts will take your questions on all things universal device identification (UDI). Our focus will be on the US and EU markets, but we will field some questions about other markets as well.
We'll first present a quick overview of UDI requirements and timelines and then address topics from our audience. Bring your questions about UDI labeling requirements, GUDID, EUDAMED implementation, and anything else related to UDI. We look forward to seeing you there!
This virtual Q&A will take place in Regulatory Exchange, RAPS’ online members-only community.
Registration Fees & Deadlines
Free
Learning Objectives
- Understand what a global UDI strategy is and why it is important
- Get your specific UDI questions answered — with a focus on the US and EU markets
- Hear from other regulatory professionals about their concerns and questions about UDI compliance
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
James Giantousos
Founder & CEO — Rimsys
James is a quality assurance and regulatory affairs professional with a diverse background in the medical device, pharmaceutical and biologics industries. His experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and Class I, II, and III devices. He also 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’s degree in operations management as well as a master of business administration with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
Adam Price
Director of Technical Programs — Rimsys
Adam 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 within the Rimsys platform. Prior to joining Rimsys, Adam was the head of post market surveillance and service quality at Philips Healthcare. While at Philips, he focused on the development of post-market strategies and solutions to meet the changing regulatory demands of the global market. Adam holds a bachelor’s degree in mechanical engineering and a master of business administration from the University of Pittsburgh.
Bruce McKean
Director of Regulatory — Rimsys
Bruce has 30 years of medical device industry experience as a quality and regulatory professional specializing in regulatory compliance related to mergers and acquisitions, facility relocations, audits, and design controls. During his career, Bruce has focused on implementing and maintaining quality systems, overseeing product submissions and regulatory strategies internal to his company and for newly acquired companies, leading corporate Q&R audit programs, and performing Q&R due diligence audits on target companies. Before joining Rimsys, he served as director of Q&R programs at Philips, where he led corporate-wide initiatives that included the adoption of the Medical Device Single Audit Program (MDSAP), leading projects and establishing Q&R playbooks for mergers and acquisitions and facility relocations, and assessing the impact of EU Medical Device Regulations (MDR) on these programs. Bruce holds a bachelor’s degree in industrial engineering technology from the University of Massachusetts — Lowell.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org