- 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.
Archives: Agenda
From burden to breakthrough: next-gen CRO & Milo’s AI slash data entry, errors, and cost with no EHR integration required
- 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
How small to medium-sized companies can accelerate innovation and improve compliance through data-driven decision making
- 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
From concept to market – hurdles for AI-driven medical devices
- 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
CASE STUDY Bouncing back on the path through NB’s question rounds – challenges and lessons learned during certification of clinical evaluation (class IIb and III)
- 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?
END OF DAY 1
End of conference
Propelling healthcare innovation: the crucial role of real-world data for medical device companies
- Exploring ways RWD can accelerate innovation
- Regulatory, post-market surveillance and market access
- Improved patient outcomes
PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
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