Medical Device & Diagnostic Labeling Conference

A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, May 14

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

9:15   SMALL GROUP DISCUSSION: CRITICAL FACTORS IN PREPARING DEVICE LABELS FOR EU MDR COMPLIANCE
As obstacles continue to appear throughout the evolving process of applying for and receiving approval for updated EU MDR and IVDR labeling certifications, identifying consistent processes that reliably yield positive results and that can be applicable to a broad range of device labels becomes necessary to keep up with ongoing deadline adjustments. This interactive discussion will break the audience into self-determined groups to discuss strategies to implement that have assisted these procedures the most, in order to simplify and accelerate labeling regulatory compliance approvals.
Natalie Velazquez, Sr. Labeling Manager
PHILIPS

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   NAVIGATING THE CULTURAL AND REGULATORY CHALLENGES OF ADOPTING STRUCTURED CONTENT AUTHORING FOR MEDICAL DEVICE DOCUMENTATION (REAL LIFE EXPERIENCE)
Many companies recognize the time- and cost-saving benefits of a CCMS and choose to implement one within their organization. However, even the most powerful tools and the best of intentions do not always lead to success without a strong change management strategy. In this session, we will discuss CCMS governance best practices to ensure a successful rollout and sustained ROI.
Josh Steen, Principal Business Architect
RWS

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   AUTOMATION & AI ARE COMING TO ARTWORK & LABELING. ARE YOU READY?
Automation and AI are set to revolutionize artwork and labeling processes, offering transformative solutions that enhance efficiency, accuracy, and compliance. This session will cover how companies can prepare for the coming change.
Samantha Thompson, Strategic Account Executive – Pharmaceutical
ESKO

2:30   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
Jennifer Love, PHILIPS
Laura Johnson, BRACCO MEDICAL TECHNOLOGIES

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, May 15

8:00   REGISTRATION & WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   STANDARDIZING PROCESSES FOR STREAMLINED RELEASES TO A GLOBAL MARKET
• Comparing key similarities between global labeling requirements
• Integration of all unique global identifiers into one device portfolio
• Harmonizing data received and processed on international levels
Jennifer Love, Sr. Manager, Regulatory Labeling
PHILIPS
Natalie Velazquez, Sr. Labeling Manager
PHILIPS

9:15   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
Ruth Flaa, Senior Technical Writer
BRACCO MEDICAL TECHNOLOGIES

10:00   COFFEE & NETWORKING BREAK

10:30   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

11:15   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

12:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:00   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

1:45   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

2:30   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

3:15   COFFEE & NETWORKING BREAK

3:45   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

4:30   PROVIDING NECESSARY TRANSLATIONS WITH SUSTAINABILITY IN MIND
• Defining of product labeling requirements
• Potential for outsourcing 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

5:15   Closing Remarks & Conference Conclusion