13th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2025

Hear fresh insight on regulatory changes and hottest technologies impacting European MedTech trials

28 - 29

January

2025
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
  • Why partner?
  • Contact Us
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Why attend?

The meeting place for healthcare pioneers and innovators

➠ Meet and hear from key MedTech manufacturers and solution providers in order to streamline your clinical processes and accelerate your overall trial timelines

➠ Hear from 15+ clinical operations and regulatory affairs professionals from medical device manufacturers on a range of topics around running a trial effectively, working with CROs and navigating regulations

120+

Attendees

20+

Exhibitors

20+

Speakers

120+

Attendees

20+

Exhibitors

20+

Speakers

Agenda

  • 28 Jan 2025
  • 29 Jan 2025
Expand All

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

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

9 AM

The impact of the EU’s AI Act on the medical device sector

  • 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

9:30 AM

Session reserved for event sponsor

10 AM

CASE STUDY AI and software-as-a-medical product development and commercialization: challenges and new developments

  • 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 and patient trust in AI and SaMD

Speakers

Carmen Bellebna
Director Regulatory Affairs & Quality Management, deepeye Medical

10:30 AM

Session reserved for event sponsor

11 AM

Morning refreshments and networking break

11:30 AM

Exploring the future of medical device and drug combination products: insights from EMA and key considerations for MR and MDR compliance

  • 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

12 PM

Session reserved for event sponsor

12:30 PM

Navigating clinical data requirements for CE mark certification

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

Speakers

Anna Mayer
Lead Auditor, Non Active Medical Devices, TÜV SÜD

1 PM

Lunch and networking

2 PM

Commercialization of innovations and scaling up with the right business model

  • 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

2:30 PM

Session reserved for event sponsor

3 PM

Examining companion diagnostic clinical performance studies under IVDR

  • Challenges and requirements of the CPS application process for CDx
  • Interventional clinical performance study requirements as per IVDR
  • Insights on optimizing the CPS process through effective planning and implementation

Speakers

Prutha Pednekar
International Regulatory Affairs IGTD, Philips

3:30 PM

Afternoon refreshments and networking

4 PM

Addressing the investment gap in medical devices: challenges and opportunities

  • 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

4:30 PM

Session reserved for event sponsor

5 PM

INTERACTIVE SESSION Streamlining compliance: agile certification for AI medical devices in the European market

  • 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
  • Exploring TÜV AI.Lab’s approach to certification
  • Understanding the importance of effective change management in maintaining compliance throughout the lifecycle of AI medical devices

Speakers

Alexander von Janowski
Process Manager Agile Certification of AI Medical Devices, TÜV AI.Lab

5:45 PM

Chairperson’s closing remarks

Speakers

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

END OF DAY 1

8:15 AM

Registration and refreshments

8:45 AM

Chairperson’s opening remarks

Speakers

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

9 AM

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

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

Speakers

Stephen Gilbert
Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health
Methee Schreuder
Senior Clinical Operations Manager, Xeltis
Mark Cregan
Medical Expert, Medaxis
Luca Franceschini
Clinical Project Manager, Aboca
Pavel Kusnierik
Head, Regulatory Affairs, Contipro

9:30 AM

Overcoming patient recruitment challenges in medical device clinical trials

  • Solutions and strategies to overcome recruitment challenges
  • Streamlining trial design
  • Leveraging technology and data

Speakers

Mark Cregan
Medical Expert, Medaxis

10 AM

Session reserved for event sponsor

10:30 AM

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?

Speakers

Renate Cizkova
Head of Clinical Department, ELLA-CS

11 AM

Morning refreshments and networking

11:30 AM

Integrating medical device cybersecurity: shaping the landscape of 2025

GlobalData Thematics representative

12 PM

Session reserved for event sponsor

12:30 PM

Exploring how digital platforms and telemonitoring are shaping clinical thinking and decision making

  • 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

1 PM

Lunch and networking

2 PM

Using AI to enhance clinical trial design and efficiency

  • 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

2:30 PM

Session reserved for event sponsor

3 PM

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

Speakers

Herbert Mauch
Director Clinical Operations EMEA, Cochlear AG

3:30 PM

Afternoon refreshments and networking

4 PM

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

RT 3 - 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

5 PM

End of conference

Speakers

Select a speaker to learn more

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

Session Details:

Chairperson’s opening remarks

2025-01-29, 8:45 AM

Session Details:

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

2025-01-29, 9:00 AM

Session Details:

Chairperson’s opening remarks

2025-01-28, 8:50 AM

Session Details:

The impact of the EU’s AI Act on the medical device sector

2025-01-28, 9:00 AM

Session Details:

Chairperson’s closing remarks

2025-01-28, 5:45 PM

View In Agenda
Next speaker
Back
Carmen Bellebna
Director Regulatory Affairs & Quality Management, deepeye Medical

Carmen Bellebna is a seasoned professional in the medical device and healthcare technology sector, with a diverse background spanning biotechnology, quality management, and regulatory affairs. She holds multiple advanced degrees, including a Master's in Health and Medical Management, and diplomas in Biotechnology and Industrial Engineering.

Currently, Carmen serves as the Director of Quality & Regulatory Affairs at Deepeye Medical GmbH, where she spearheads the CE marking process for AI-powered medical device software. Her focus is on Software as a Medical Device (SaMD) in the ophthalmology sector, specifically working on treatment planning systems for neovascular Age-related Macular Degeneration (nAMD). Her expertise in implementing quality management systems compliant with MDR 2017/745 and EN ISO 13485 ensures cutting-edge medical software meets rigorous regulatory standards.

With over two decades of experience, Carmen has held key positions at notable organizations such as TÜV SÜD PS GmbH, where she worked as a Lead Auditor for medical devices. Her proficiency extends to auditing quality management systems, assessing technical documentation, and evaluating sterilization processes across various medical device categories.

Session Details:

CASE STUDY AI and software-as-a-medical product development and commercialization: challenges and new developments

2025-01-28, 10:00 AM

View In Agenda
Next speaker
Back
Anna Mayer
Lead Auditor, Non Active Medical Devices, TÜV SÜD

Session Details:

Navigating clinical data requirements for CE mark certification

2025-01-28, 12:30 PM

View In Agenda
Next speaker
Back
Miguel Hernandez
Medical Device Safety & Vigilance Lead, UCB

Dr. Miguel Hernandez is a general physician with postgraduate studies in the field of clinical and medical Bioethics. He has been involved in the area of clinical research mainly focused on Medical Devices over the past 12 years, where he has been responsible for pre-market safety reporting and post-market surveillance across Europe, U.S.A., Canada and Japan. His main area of therapeutical expertise include orthopedics, interventional cardiology, CNS, dermatology, rheumatology and women’s health.

He has worked in diverse roles across the industry, including medical device companies and CROs, in roles such as  Safety Officer and Medical Management, Clinical Research Physician, Medical Device Safety Manager, Head of Materiovigilance, and is currently working as Medical Device and Safety Surveillance Lead for UCB,  where is heavily involved in the transition from the Directive 2007/47/EC to the MDR (2017/745) in order to meet regulatory compliance.

Session Details:

Exploring the future of medical device and drug combination products: insights from EMA and key considerations for MR and MDR compliance

2025-01-28, 11:30 AM

View In Agenda
Next speaker
Back
Prutha Pednekar
International Regulatory Affairs IGTD, Philips

Session Details:

Examining companion diagnostic clinical performance studies under IVDR

2025-01-28, 3:00 PM

View In Agenda
Next speaker
Back
Max G. Ostermeier
CEO and Founder, Implandata Ophthalmic Products

Session Details:

Addressing the investment gap in medical devices: challenges and opportunities

2025-01-28, 4:00 PM

View In Agenda
Next speaker
Back
Alexander von Janowski
Process Manager Agile Certification of AI Medical Devices, TÜV AI.Lab

Session Details:

INTERACTIVE SESSION Streamlining compliance: agile certification for AI medical devices in the European market

2025-01-28, 5:00 PM

View In Agenda
Next speaker
Back
Alexander Stanke
Chief Operating Officer & Managing Director, Preventicus

Session Details:

Commercialization of innovations and scaling up with the right business model

2025-01-28, 2:00 PM

View In Agenda
Next speaker
Back
Danish Mairaj
Principal Engineer Medical Device Design, Resyca

Session Details:

Using AI to enhance clinical trial design and efficiency

2025-01-29, 2:00 PM

View In Agenda
Next speaker
Back
Renate Cizkova
Head of Clinical Department, ELLA-CS

Session Details:

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)

2025-01-29, 10:30 AM

View In Agenda
Next speaker
Back
Mark Cregan
Medical Expert, Medaxis

Session Details:

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

2025-01-29, 9:00 AM

Session Details:

Overcoming patient recruitment challenges in medical device clinical trials

2025-01-29, 9:30 AM

View In Agenda
Next speaker
Back
Karel Volenec
CEO, ELLA-CS

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-01-29, 4:00 PM

View In Agenda
Next speaker
Back
Methee Schreuder
Senior Clinical Operations Manager, Xeltis

Over the last 7 years I have worked in the Medical Device industry, with a primary focus on clinical operations management. I have accumulated a wealth of international experience, executing trials in all regions of the world; Americas (including US), EMEA and APAC (including China). This has given me many opportunities to manage both internal and external partners, and maintain strong multidiciplinary/multicultural relationships. I have also been fortunate to gain experience with managing all stages of clinical trials, notibly with multiple Early Feasibility, First-in-Human and Pivotal studies in the pre-market space, as well as, a global post-market Registry during my career. To date, most of my experience is rooted in the cardiovascular field, having worked on studies for Cardiac Resynchronization Therapy, Mechanical Circulatory Support, Coronary Arterial Bypass Grafts, and Pumonary Heart Valves. In the past years, I have also branched into other indications, such as Vascular Access Grafts (for hemodialysis) and Peripheral Arterial Grafts in the field of vascular surgery.

Session Details:

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

2025-01-29, 9:00 AM

View In Agenda
Next speaker
Back
Roxana Mittler-Matica
Senior Physician in Neurosurgery & Digital Transformation Lead, DRK-Schmerz-Zentrum Mainz Alice Hospital

Session Details:

Exploring how digital platforms and telemonitoring are shaping clinical thinking and decision making

2025-01-29, 12:30 PM

View In Agenda
Next speaker
Back
Herbert Mauch
Director Clinical Operations EMEA, Cochlear AG

Session Details:

Propelling healthcare innovation: the crucial role of real-world data for medical device companies

2025-01-29, 3:00 PM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-01-29, 4:00 PM

View In Agenda
Next speaker
Back
Luca Franceschini
Clinical Project Manager, Aboca

Session Details:

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

2025-01-29, 9:00 AM

View In Agenda
Next speaker
Back
Yvonne Hoogeveen
Director, Clinical Affairs, Wellinq

Following attainment of a BSc in Biology at the University of Adelaide, Australia, I moved to the Netherlands to continue my education (Master degree and PhD). Started working in Medical Device industry (Cordis Europa NV, the Netherlands) in clinical research in 1991, participating in the multidisciplinary team developing and bringing to the market a hydrodynamic thrombectomy catheter for cardiology and peripheral applications (World-Wide, excl. USA), and permanent and temporary vena cava filters (World-wide including USA). Thereafter worked in academic research in interventional radiology (RadboudUMC Nijmegen) as well simultaneously continuing my work (from 2009 to current -Wellinq) in clinical research in device development projects (Urodynamic catheter & FFR catheter – combining catheter and sensor technology, peripheral angiography catheter and (DCB-)PTCA  devices). Following instigation of the MDR, the main focus was on achieving MDR certification for the marketed legacy devices. All reviewed dossiers were granted CE under MDR.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-01-29, 4:00 PM

View In Agenda
Next speaker
Back
Pavel Kusnierik
Head, Regulatory Affairs, Contipro

Session Details:

PANEL DISCUSSION Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

2025-01-29, 9:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-01-29, 4:00 PM

View In Agenda
Next speaker
Back
Ingo Horak
Business Development, Luscii

Session Details:

Exploring how digital platforms and telemonitoring are shaping clinical thinking and decision making

2025-01-29, 12:30 PM

View In Agenda
Next speaker

Plan Your Visit

Venue

Holiday Inn Munich City Centre

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Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

  • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
  • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

Event reach

  • 150+ attendees each year
  • 80% attendees C-suite level

 

Take a look at our current sponsors

Media Centre

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Alex Purnell

Senior Sponsorship Manager

+44 204540 7786

SPEAKING OPPORTUNITIES

Louisa Manning

Programme Director

+44 207661 906

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Alex Purnell

Senior Sponsorship Manager


+44 204540 7786

SPEAKER ENQUIRES

To enquire about speaking opportunities for the conference, please contact:

Louisa Manning

Programme Director


+44 207661 906