Archives: Agenda

Where conversational AI and automation have actually reduced cost-to-serve.

Case studies showing measurable gains in claims and customer operations.

How to scale AI safely with governance, transparency, and human oversight, what has changed in workflows, data and proof points from real deployments.

MODERATOR: Cherie Landman, Head of Sales, EMEA, Boost AI

• Firsthand insight into Kurtosys’ digital accessibility journey—why they got started, what they’ve achieved, and what they’ve learned along the way.
• Key challenges they faced in scaling accessibility across complex digital experiences, multiple teams, and high volumes of content—and how they navigated them.
• How they’re maturing their accessibility program with a focus on long-term sustainability, organizational alignment, and measurable business impact.

• Enhancing patient recruitment and streamlining data capture using Milo’s AI-driven capabilities
• Integrating seamlessly into existing clinical research workflows for improved efficiency
• Maintaining compliance while driving efficiency in clinical research with Milo
• Simplifying processes and optimizing outcomes to reshape the future of clinical trials

• Challenges in leveraging clinical and vigilance data, leading to delays and untapped potential
• How to overcome this and make your health data available for secondary use in your organization
• How this accelerates market access and reduces workload and costs

• Starting on the right foot: Considerations for training and validation of AI-driven medical devices
• Clinical performance: Steps to efficient clinical validation based on case example
• Market entry: Hurdles with Notified Body review and approval
• What happens next: Iterating in the post-market setting

• Literature search – what literature source is relevant for my MD?
• Exploring how to align acceptance criteria for safety and performance with State of the art
• Is the clinical evidence sufficient for the entire dimensional range of my medical device?

• Exploring ways RWD can accelerate innovation
• Regulatory, post-market surveillance and market access
• Improved patient outcomes

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry.

RT1 – Tackling challenges and harnessing real-world data for medical device companies

Herbert Mauch, Director Clinical Operations EMEA, Cochlear AG

RT2 – Do Notified Bodies’ dedicated programs help or hinder new medical device manufacturers?

Karel Volenec, CEO, ELLA-CS

RT3 -Building a relationship with your study team – how to get good and timely results from everyone included

Pavel Kušnierik, Head of Regulatory Affairs, Contipro

RT4 – PMCF legacy devices: the PMCF Plan, expectations and challenges for obtaining user feedback

Yvonne Hoogeveen, Director Clinical Affairs, Wellinq