Medical Device & Diagnostic Labeling Conference

A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, September 24

7:30   REGISTRATION & WELCOME COFFEE 

8:20   CHAIRPERSON’S OPENING REMARKS 

8:30   KEYNOTE PANEL: 2025 EVOLUTION OF LABELING ROLE IN MEDICAL DEVICE & DIAGNOSTIC LANDSCAPES
• Compliance amidst ongoing regulatory requirement changes
• Strengthening digital capabilities in line with global trends
• Global move towards implementing official label regulations
• Accelerating the notified body certification approval process
Panelists:
Dawn Fowler, Medtech Labeling & UDI Expert
Matt Wolf, VERATHON
Alejandro Manunta, INTEGER
Mia Beste, MEDTRONIC 

9:15   PROVIDING NECESSARY TRANSLATIONS WITH SUSTAINABILITY IN MIND
• Defining of product labeling requirements
• Potential for outsourcing translation translation services
• Utilizing electronic informational mediums whenever available
• Comprehensive design reviews for minimizing print error waste
Laura Clark, Technical Communications Associate Director – GHI, Regulatory
EXACT SCIENCES 

10:00   COFFEE & NETWORKING BREAK

10:30   UKCA MARK EXPLICIT DECLARATIONS AND DEADLINES FOR COMPLIANCE
• Labeling specifications for ensuring UKCA mark approvals as needed
• Explicit deadlines to gain approval according to previous CE markings
        » MDR/IVDR/IVDD CE
        » MDD/AIMDD CE
• Suggested timelines for preparation of changes and enforcements
Neil Plumridge, Regulatory Affairs Manager
BIVDA 

11:15   KALLIK SPONSORED SESSION (TBA)

12:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:00   FIRESIDE CHAT: NOTIFIED BODY PERSPECTIVE ON PROMPT EU IVDR COMPLIANCE
As IVD device manufacturers continue to pursue certification with the IVDR updated regulations for both new and legacy products, it remains critical for labeling executives to thoroughly understand the conditions labels must adhere to. This interview formatted session will enable the audience to address specific questions to notified body experts providing clarity into concerts of essential and timely importance.
Haijuane Jane Li, Lead Auditor and Product Reviewer
GMED NA 

1:45   SMALL GROUP DISCUSSION: COST-EFFECTIVE TOOLS FOR MAINTAINING LEGACY DEVICE COMPLIANCE WITH ONGOING REGULATORY UPDATES
With manufacturers steadily expanding medical device releases within the evolving global market, labeling requirements continue to evolve at the same pace, tasking labeling executives with the ongoing cycle of maintaining label compliance for all legacy devices. This interactive discussion will break audience members into self-determined groups to share proven tactics in keeping up to date of the newest regulations, ensuring updated performance data availability, and promptly upgrading labeling strategies as needed.
Laura Johnson, Manager, Labeling Center of Excellence
BRACCO MEDICAL TECHNOLOGIES

2:30   DEVELOPING A PROACTIVE UDI GLOBAL LABELING STRATEGY
Kurt Hammond, Global RA UDI Labeling Manager
BD 

3:15   COFFEE & NETWORKING BREAK

3:45   MAXIMIZING UDI PRACTICAL USES WITH ONGOING GLOBAL EXPANSIONS
• Ensuring adequate oversight for global scale UDI implementation
• Recognition of distinct UDI applications and requirements by region
• Harmonization of UDI requirements with international regulations
Dawn Fowler, Medtech Labeling & UDI Expert 

4:30   EUDAMED DATABASE ROLLOUT TIMELINE AND USE PREPARATION
• Evaluation of latest timeline declaration and plausibility
• Similarity comparison to comparable international databases
        » Australia TGA
        » Saudi Arabia MDDB
• Preparation for maximizing database contributions and utilization
• Areas included preemptively in EUDAMED registration obligations
Dawn Fowler, Medtech Labeling & UDI Expert

5:15   Closing Remarks & End of Day 1

Day Two Agenda
Thursday, September 25

8:30   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   LABELING REQUIREMENTS INTRODUCED WITHIN FLOURISHING GLOBAL MARKETS AS OF 2025
• Comparing pilots in new regions with established market regulations
       » Egypt
       » Saudi Arabia
       » Brazil
• Expected digital labeling permissions allowed for immediate use
• Implications of global expansion of labeling regulatory requirements
Christine Wahba, Sr. Regulatory Affairs and QA Specialist
ALIGN TECHNOLOGY

9:45   PANEL DISCUSSION: EFFECTIVELY GAINING NOTIFIED BODY APPROVAL FOR LABELING CERTIFICATION MARKS
• Circumventing common reasonings for design approval challenges
• Securing alignment of label information, symbols, and translations
• Precise questioning to maximize appeal cycle process productivity
• Expanding on labelling details provided for further proof of accuracy
Christine Wahba, ALIGN TECHNOLOGY
Honey Dayani, INTUITIVE
Laura Johnson, BRACCO MEDICAL TECHNOLOGIES

10:30   COFFEE & NETWORKING BREAK

11:00   LEGAL PERSPECTIVE: APPLICATIONS OF FDA LDT RULING ON LABELING FOR LABORATORIES
• Deadlines for compliance across all stages of LDT phase out policy
• Labeling expectations and applicable requirements for non-distributors
• Globally equivalent regulations likely to harmonize subsequently
• Developing minimal essential use disclosures for confidentiality
Laura Dona, Associate
ARNALL GOLDEN GREGORY LLP

11:45   REAL-WORLD APPLICABILITY: APPLICATIONS OF FDA LDT RULING ON LABELING FOR LABORATORIES
• Deadlines for compliance across all stages of LDT phase out policy
• Labeling expectations and applicable requirements for non-distributors
• Globally equivalent regulations likely to harmonize subsequently
• Developing minimal essential use disclosures for confidentiality
Irene Hsieh, Sr. Director, Regulatory Affairs & Quality Assurance
CLEARNOTE HEALTH

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   PANEL DISCUSSION: ALIGNING LABELING TEAMS MINDSET TO EMBRACE ADVANCING TECHNOLOGIES
• Continuous trainings in line with labeling technological advances
• Pinpointing challenging tasks with potential for supplemental tech
• Addressing common concerns due to longstanding routine changes
• Cost- and time-efficiency benefits from implementing technology
Selena Ingram, FRESENIUS KABI
Matt Wolf, VERATHON
Pankaj Chandak, MEDTRONIC

2:15   TECHNOLOGICAL TOOLS TO CENTRALIZE CROSS-FUNCTIONAL RESPONSIBILITIES
• Tools available for resource sharing to improve knowledge standards
• Potential applications for stable and constant communications
• Software for improving streamlined in-house design review
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence
INTEGER

3:00   COFFEE & NETWORKING BREAK

3:30   EIFU BEST PRACTICES: CONSIDERATIONS FOR USABILITY AND COMPLIANCE
• Essential aspects of eIFU distribution, tools, and processes
• Labeling transition from print to eIFU, considering physical labels and digital formats
• Countries and regions currently accepting eIFU documentation
Selena Ingram, Sr. Labeling Technology Specialist
FRESENIUS KABI

4:15   ENSURING ADVANTAGEOUS USES OF NEW QR CODE TECHNOLOGY WITHIN LABELING
• Safety concerns regarding improper use for malicious reasoning
• Beneficial utilizations of QR Codes for digital labeling materials
• Expectations of forthcoming regulations for standardized uses
Roger Peterson, Senior Manager, Global Labeling, Regulatory
ARTHREX

5:00   Closing Remarks & Conference Conclusion