DNV at RAPS Convergence 2026

Join DNV at RAPS Convergence 2026 to connect with our experts, discuss your regulatory challenges and explore the latest developments in medical device certification.

DNV is pleased to be exhibiting and speaking at RAPS Convergence 2026, one of the leading medical device regulatory events in the United States.

  • Date: 15–17 September 2026
  • Location: Charlotte Convention Center, Charlotte, North Carolina, USA
  • DNV Booth: 507

Visit us at Booth 507 to connect with our team and learn more about current regulatory trends, including electronic Instructions for Use (eIFU) and global best practices.

Whether you're planning your MDR or IVDR certification, exploring a transfer to DNV, or seeking regulatory guidance, our experts are ready to help.

 

Featured DNV Session 

Join DNV experts throughout RAPS Convergence 2026 as they share practical insights into today's evolving medical device regulatory landscape. From global eIFU implementation and regulatory engagement to AI-enabled medical devices and conformity assessments, our speakers will discuss key developments shaping the future of medical device compliance.

Explore DNV's featured sessions below and join our experts as they discuss the latest developments in medical device regulation, certification and global compliance.

Agenda

Featured DNV Session

16 September | 16:30 - 17:30 (EDT)

Panel discussion | Navigating Global eIFU Excellence: Leveraging US and EU Best Practices for Strategic Implementation

  • Date: Wednesday, 16 September 2026
  • Time: 4:30 PM – 5:30 PM EDT

Join Diane Legere and fellow industry experts from AKRA Team, Innovatum Inc., Arthrex and Meddevo as they discuss practical strategies for implementing electronic Instructions for Use (eIFU), including the latest developments under EU Regulation 2025/1234, FDA expectations and global best practices.

Key topics

  • EU Regulation 2025/1234 and FDA expectations for eIFU
  • Building scalable eIFU strategies for global market access
  • Integrating EUDAMED, UDI and digital regulatory workflows
  • QMS readiness for electronic documentation and audit readiness
  • Applying usability engineering principles to support effective eIFU implementation

 

17 September 2026 | 13:00 - 14:00 (EDT)

Panel discussion | Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs

  • Date: Thursday, 17 September 2026
  • Time: 1:00 PM – 2:00 PM EDT

Join Dr. Kenneth Fuh alongside representatives from the European Medicines Agency (EMA) and industry experts for an interactive discussion on current regulatory developments affecting medical devices and IVDs. Attendees will have the opportunity to engage directly with the panel and gain perspectives from regulators, Notified Bodies and industry.

Key topics

  • Current regulatory developments for medical devices and IVDs
  • Perspectives from health authorities and Notified Bodies
  • Regulatory expectations and industry engagement
  • Interactive discussion on global regulatory challenges
17 September 2026 | 16:30 - 17:30 (EDT)

Discussion | Best Practices in MDR/IVDR Conformity Assessment Processes: Lessons Learned for SaMD and AI-Integrated Medical Devices

  • Date: Thursday, 17 September 2026
  • Time: 4:30 PM – 5:30 PM EDT

Join Dr. Kenneth Fuh as moderator alongside regulatory and industry experts for a discussion on best practices for MDR and IVDR conformity assessments for Software as a Medical Device (SaMD) and AI-integrated medical devices. The session will explore practical approaches to navigating evolving regulatory requirements while supporting innovation, compliance and patient safety.

Key topics

  • MDR and IVDR conformity assessment best practices for SaMD and AI-enabled medical devices
  • Technical documentation, risk management and performance evaluation
  • Implementing the EU AI Act alongside MDR and IVDR requirements
  • Post-market surveillance, real-world evidence and integrated compliance strategies

Schedule a meeting

Planning to attend RAPS Convergence 2026? Whether you'd like to discuss your certification plans, learn more about DNV's medical device certification services, or continue the conversation after our panel discussion, we’re here to help. Complete the form below to request a meeting with our team.

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