Archives: Agenda

• 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?

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

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

• Learning how the agile certification process prototype harmonizes the MDR and AI Act, creating a streamlined path for innovative AI technologies to meet stringent regulatory standards
• Understanding the importance of effective change management in maintaining compliance throughout the lifecycle of AI medical devices

• Real-world data generation for clinical studies on remote patient monitoring
• Exploring the future role of remote patient monitoring in drug approval
• The role of digital platforms in enhancing data collection for medical device trials

• Prediction of operational efficiency of clinical trials by machine learning models
• Prediction of early trial termination of clinical trials
• Prediction of adverse event reporting in clinical trials