19th Semi-Annual

MEDICAL DEVICE & DIAGNOSTIC LABELING CONFERENCE

October 13, 2026 | Virtual Event

All times Central US Time

19th Semi-Annual

MEDICAL DEVICE & DIAGNOSTIC LABELING CONFERENCE

October 13, 2026
Virtual Event

All times Central US Time

Distinguished Presenters Include:

Agenda

Tuesday, October 13

*All Times Central US Time

8:30   ZOOM SIGN-ON & VIRTUAL COFFEE

• Private & public text chat
• Interactive polling
• Tech check

8:50   OPENING REMARKS & VIDEO PROGRAM WELCOME

9:00   LABELING TRANSLATION MANAGEMENT FOR GLOBAL COMPLIANCE

• Coordinating cross-functional teams for translation accuracy and efficiency
• Implementation of review, approval, and version control workflows
• Integration of technology to manage multilingual labeling content
• Designing translations with patient comprehension and safety in mind
• Impact of cultural, linguistic, and regional differences in labeling

Richard Korn, Labeling Transformation Consultant

9:45   IMPLEMENTATION STRATEGIES FOR A GLOBAL UDI PLAN

Tania Pearson, Regulatory Systems Director
MEDTRONIC

10:30   STREAMLINING LABELING APPROVALS WITH NOTIFIED BODIES

• Strategies to anticipate and respond to Notified Body feedback
• Avoiding common labeling errors identified during Notified Body review
• Key requirements for labeling submissions under EU MDR/IVDR
• Preparing accurate, complete, and compliant labeling documentation

Sharmila Gardner, Technical Documentation Manager & Head of UK Approved Body
INTERTEK MEDICAL NOTIFIED BODY

11:15   LUNCHEON BREAK

12:15   OPTIMIZING LABEL DESIGN: HUMAN FACTORS AND USABILITY TESTING IN PRACTICE

• Application of human factors principles to medical device labeling
• Designing labels that enhance comprehension and minimize user errors
• Practical methods for conducting usability studies on labeling

Selena Ingram, Sr, Manager, Global Labeling
FRESENIUS KABI MEDTECH

1:00  UPDATE ON THE MEDTECHLABEL IHI (DIGITAL LABELING) PROJECT

The MedTechLabel (digital) project aims to standardize and harmonize the delivery practices for Medical Device (MD) and In Vitro Diagnostic (IVD) Labelling while building a digital labeling framework. The 36-month project was established and funded by the European Commission as a result of public and private partners who formed as a consortium under a European IHI initiative. The following case study will provide an update on the current status and impact of the IHI project.

Roger Peterson, Sr. Manager, Global Labeling, Regulatory
ARTHREX

1:45   CLOSING REMARKS & VIRTUAL PROGRAM CONCLUSION

Who Should Attend

Executives working within Medical Device and Diagnostic corporations that will find this program of greatest relevance are those currently working to maintain compliance with medical device and diagnostic labeling requirements, introducing and utilizing of recent digital applications, as well as those working on releasing devices to a global market.

Previous Attendees Include:

Sr. Director, Identification & Master Data, Healthcare, GS1 GLOBAL
Senior Global Master Data Analyst, HOLLISTER INCORPORATED
Director, Global Labeling, HOLOGIC
Director, Labeling Quality, INTEGRA LIFE SCIENCES
Director, Global Labeling Engineering, INTUITIVE SURGICAL
Director, Package Engineering and Product Labeling, J & J
Senior Director, Packaging and Labeling, MEDTRONIC
Senior Labeling Engineer, OLYMPUS
Labeling Specialist, R&D Labeling, PFIZER
UDI Project Lead, ROCHE DIAGNOSTICS
Director of Regulatory Affairs, RTI SURGICAL
Director, Quality Management, SIEMENS
Director, Research & Development, STRYKER
Director, Global Labeling, TERUMO BCT
Senior Labeling & Packaging Developer, VERATHON
Project Manager UDI & GS1, WRIGHT MEDICAL