• Highlighting the main components of the act
• How the AI Act complements or adds to MDR requirements
• Balancing innovation with safety
• Strategies to navigate the AI Act

Speakers

Stephen Gilbert

Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health

Navigating the journey from preclinical studies to market approval is a critical and complex process for medical devices. This presentation outlines a streamlined approach to ensure regulatory compliance, efficient development, and timely market access

• The importance of correct device classification and its impact on regulatory pathways.
• Strategies to define a comprehensive regulatory roadmap tailored to global requirements.
• Key preclinical tests to establish safety and performance baselines
• Insights into aligning preclinical findings with a robust clinical protocol
• Criteria for selecting the right Notified Body to streamline certification
• Best practices for creating a well-structured technical file to facilitate regulatory review

Speakers

Enrico Perfler

Founder, 1Med

• Navigating the evolving regulatory landscape for AI and software as medical devices
• Integrating AI into existing healthcare systems
• Managing the lifecycle of AI products
• Gaining clinical experience by users of AI based SaMDs

Speakers

Carmen Bellebna

Director Regulatory Affairs & Quality Management, deepeye Medical

This session will explore the pivotal role of clinical technology and AI in driving the success of Medtech trials, focusing on how a unified, AI-enabled platform can serve as the foundation for an expanded data health ecosystem. Attendees will learn the benefits of interconnected data flows, starting with purpose-built, simple electronic data capture (EDC) systems for Medtech trials, scaling by integrating Imaging capabilities, leveraging AI for enhanced data analysis, and enabling seamless one-click imports of Electronic Health Records (EHRs). This approach eliminates redundancies, enhances data integrity, reduces site burden, and can bridge clinical trial data with real-world evidence to improve device observation and long-term insights. By adopting an integrated, AI-driven platform, sponsors can meet current trial demands while building a robust data ecosystem to advance future patient care.

• Recognize the importance of choosing a scalable platform to future-proof clinical trials and enable seamless connections between trial data and real-world evidence for long-term impact
• Understand the role of a unified cloud-based platform in creating a connected data health ecosystem tailored to Medtech trials
• Explore how integrating Imaging and EHR data can enhance operational efficiency, data accuracy, and site engagement

Speakers

Anthony Arena

Solution Sales Specialist – Connected Data, Medidata

• Understanding the increasing trend of combining medical devices and drugs
• Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
• Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
• Identifying compliance requirements and implications based on the device's primary mode of action
• Presenting various regulatory pathways available for combination products
• Understanding how partnerships can drive innovation and development in this domain

Speakers

Miguel Hernandez

Medical Device Safety & Vigilance Lead, UCB

• Findings from Greenlight Guru’s 2025 State of Medical Device Industry Report, providing valuable insights into the latest trends, challenges, and innovations in the medical device landscape
• Key industry shifts, including evolving regulatory demands, advancements in clinical technology, and strategies that successful companies are using to navigate complex quality and clinical requirements
• A session for MedTech professionals looking to stay ahead of industry changes and drive forward-thinking quality and clinical practices
• Be among the first ones to access the report before its public release

Speakers

Páll Jóhannesson

Executive Vice President, Greenlight Guru

• Understanding regulatory expectations
• Designing and conducting clinical investigations
• Balancing data sufficiency with practicality

Speakers

Anna Mayer

Clinical Auditor, TÜV SÜD

• Exploring the conjunction between medical devices and digital health
• What are the success factors?
• Dos and don’ts and best practice examples

Speakers

Alexander Stanke

Chief Operating Officer & Managing Director, Preventicus

• Planning of a robust study design
• Common hurdles during the start-up phase
• Adhering to timelines for event reporting to regulatory authorities
• Considering financial aspects during the course of a study

Speakers

Frank Maier

Director, Project Management, RQM+

• Challenges and opportunities from a technology, economic perspective
• Geopolitical, legal and regulatory changes and their impact from an ecosystem perspective

Speakers

Pradipto Kolay

Global R&D Leader, Philips

• Analysis of current trends in investment within the medical device sector and exploring what factors contribute to the investment gap
• Discussing financial, operational and regulatory challenges that startups and small to medium-sized companies face in the industry and how to overcome them
• Identifying potential solutions for improving the investment landscape

Speakers

Max G. Ostermeier

CEO and Founder, Implandata Ophthalmic Products

• Examine critical regulatory pathways, with strategic insights for achieving market clearance/approval in the US and EU
• Present streamlined approaches for planning and designing effective clinical studies, highlighting the benefits of budgeting early
• Discuss efficient processes for regulatory submissions and applications, from clinical study conduct to market clearance/approval

Speakers

Frank Keulen

Director, Program Delivery, MedTech, Premier Research

Michael Edwards

Senior Director, Regulatory Affairs, MedTech, Premier Research

• 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

Speakers

Alexander von Janowski

AI Certification Manager, TÜV AI.Lab

Danish Mairaj

Principal Engineer Medical Device Design, Resyca

Pradipto Kolay

Global R&D Leader, Philips

Piet Smet

Division Head Clinical, QBD Group

• Discussing challenges in communication, project management, and regulatory compliance
• Role of CROs in fostering innovation in medical device development
• Case studies highlighting successful collaborations and lessons learned
• Emerging trends and technologies shaping future collaborations

Speakers

Methee Schreuder

Senior Clinical Operations Manager, Xeltis

Mark Cregan

Medical Expert, Medaxis

Luca Franceschini

Clinical Project Manager, Aboca

Pavel Kusnierik

Head, Regulatory Affairs, Contipro

• Commercial pressure versus Clinical realities
• Managing the tripartite relationship between Sponsor, CRO and Site.
• Key drivers of failure (and success!)
• The changing clinical trial landscape: Adapting to new challenges

Speakers

Mark Cregan

Medical Expert, Medaxis

Conducting medical device clinical trials in Europe and the UK presents unique challenges due to varying regulatory landscapes and operational complexities. This session highlights the key issues faced by researchers and companies in this region, including:

• Planning for varying local and regional regulatory requirements
• Coordinating operations across multiple countries
• Streamlining patient recruitment and data management

Speakers

Stacy Gardner

Director of Clinical Affairs, MCRA – an IQVIA business

• 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?

Speakers

Renate Cizkova

Head of Clinical Department, ELLA-CS

• The impact of AI and cyber threats on medical devices
• The cyber challenges 2025 may bring
• How regulators and tech companies are meeting the AI challenge

Speakers

David Bicknell

Principal Analyst, Thematic Research, GlobalData

• 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

Speakers

Dr. Adnan Shah

Senior Consultant Medical Writing, Deloitte

Dr. Heike Fischer

Director Clinical Research, Deloitte

• 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

Speakers

Roxana Mittler-Matica

Senior Physician in Neurosurgery & Digital Transformation Lead, DRK-Schmerz-Zentrum Mainz Alice Hospital

Ingo Horak

Business Development, Luscii

• 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

Speakers

Danish Mairaj

Principal Engineer Medical Device Design, Resyca

• 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

Speakers

Andreas Beust

Chief Executive Officer, GCP-Service

• 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

Speakers

Chems Hachani

CEO, Eclevar Medtech

Dr. Nikhil A. Khadabadi, MD, MRCS (Edin), MS Ortho

Chief Medical Officer, Eclevar

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

Speakers

Herbert Mauch

Director Clinical Operations EMEA, Cochlear AG

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

Speakers

Karel Volenec

CEO, ELLA-CS

Herbert Mauch

Director Clinical Operations EMEA, Cochlear AG

Yvonne Hoogeveen

Director, Clinical Affairs, Wellinq

Pavel Kusnierik

Head, Regulatory Affairs, Contipro