Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)

1.0 RAC Credits Members: $0 | Nonmembers: $25
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process  (On-Demand)

This is an On-demand recording from March 2022.

This event is brought to you by

While UDI and other product labeling information have typically been maintained separately from other regulatory information, the growing complexity of supporting multiple markets is introducing compliance challenges. Companies can’t treat it simply as an operational or supply chain process.

Regulatory professionals are spending an increased amount of time focusing on UDI due to the implementation of the FDA UDI, the introduction of new UDI requirements in the EU MDR and EU IVDR regulations, and many countries around the world implementing aspects of UDI. 

This virtual program will break down the complexity of UDI by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.

Learning Objectives 

Attendees will learn:

  • Where UDI requirements are being implemented 
  • The timeline for UDI requirement rollout in different regions
  • Which types of products will be impacted by new UDI regulations
  • UDI data requirements and issuing entities for each market
  • Best practices for capturing and managing "master" UDI data for reuse across submissions

Who Should Attend? 

  • Regulatory affairs professionals and leaders in the MedTech industry (medical device, IVD, and combination products)
  • IT professionals, business analysts, and project managers who support regulatory activities in the MedTech industry



The agenda may vary based on changing requirements.


Bruce McKean

Bruce McKean is the director of regulatory at Rimsys Regulatory Management Software. He has more than 25 years of medical device industry experience as a regulatory professional specializing in quality and regulatory (Q&R) compliance, design controls, and Q&R-related mergers and acquisitions. During his career, McKean has focused on implementing and maintaining design controls, product submissions, quality management systems internal to his company and for newly acquired companies, corporate Q&R internal audit programs, and performing Q&R due diligence audits on target companies. Prior to joining Rimsys, he served as director of Q&R operations at Philips Healthcare, where he led a corporate-wide Medical Device Single Audit Program (MDSAP) compliance initiative and was focused on the implementation of the EU Medical Device Regulation (EU MDR).

James Gianoutsos

James Gianoutsos is the founder and president of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate and create regulatory order for medtech companies. Gianoutsos is a quality assurance and regulatory affairs professional, who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and postmarket surveillance of drug products and Class I, II, and III devices. Gianoutsos has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP and 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 Investigational New Drug Applications (INDs). He holds an MBA with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.


Contact the RAPS Solutions Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org  
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