Event agenda
Wednesday, 26 February 2025
09:00 - 09:10
Organizers’ Welcome
- PLENARY SESSION 1: MDR/IVDR transition and innovation
2 speakers
09:00 - 17:00
Exhibition
09:10 - 09:20
Opening Speech
- PLENARY SESSION 1: MDR/IVDR transition and innovation
Speaker: Prof dr. Levente Kovács, rector, Obuda University
09:20 - 09:45
What lies ahead for the European medical technology industry?
- PLENARY SESSION 1: MDR/IVDR transition and innovation
Speaker: Jesus Rueda Rodríguez, Director-General of Strategies and Special Projects
09:45 - 10:00
BVMed's MDR/IVDR development proposals (and their current status)
- PLENARY SESSION 1: MDR/IVDR transition and innovation
Speaker: Dr. Christina Ziegenberg, Head of Regulatory Affairs, BVMed
10:00 - 10:15
Digitalization as the key to future development of MDR and IVDR
- PLENARY SESSION 1: MDR/IVDR transition and innovation
Speaker: Michael M. Kania, CEO, meddevo dytab GmbH
1 speaker
10:15 - 10:30
Coffee Break
10:30 - 11:15
The state and outlook of the European medical technology industry
- PLENARY SESSION 1: MDR/IVDR transition and innovation
Moderator: Miroslav Palát, President CzechMed
2 speakers
11:15 - 11:45
MDR - IVDR transition experiences of Notified Bodies
- PLENARY SESSION 2: MDR/IVDR transition experiences
Participants: Ana Pribakovic Borstnik, Medical department director, SIQ, Slovenia Curtis Riley, Head of Medical, Intertek Notified Body Tomasz Koeber, Head of Medical Devices Certification Department, PCBC Poland
1 speaker
11:45 - 12:00
Q&A
- PLENARY SESSION 2: MDR/IVDR transition experiences
12:00 - 13:30
Lunch Break
13:30 - 14:00
MDR - IVDR transition consultant experiences
- PLENARY SESSION 2: MDR/IVDR transition experiences
4 speakers
14:00 - 14:15
I3HIES – An International Health Innovation Ecosystem to address MDR challenges
- PLENARY SESSION 2: MDR/IVDR transition experiences
Speaker: Dr Zsolt Pásztor, Director of International Relations of Mediklaszter
14:15 - 14:30
The medical device industry is in the crosshairs of the new horizontal requirements
- PLENARY SESSION 3: New horizontal requirements
1 speaker
14:30 - 14:45
AI Meets Medtech
- PLENARY SESSION 3: New horizontal requirements
Speaker: Thorsten Stumpf, Project Lead for Regulatory Affairs, Software & AI at Metecon
14:45 - 15:00
Coffee break
15:00 - 15:20
The AI Ecosystem in Pharma and Healthcare: Integrating Traditional and Generative AI Approaches
- PLENARY SESSION 4: The practical applications of AI
Speaker: Gyula Kovács, co-founder and managing director, Neuron Solutions Ltd.
15:20 - 15:35
Quantitative Medical Imaging: The Future of Diagnostics
- PLENARY SESSION 4: The practical applications of AI
1 speaker
15:35 - 15:50
AI-Driven Integration of Pharmacovigilance into the Drug Discovery Pipeline
- PLENARY SESSION 4: The practical applications of AI
Speaker: Dr. Péter Antal, associate professor, Department of Artificial Intelligence and Systems Engineering Budapest University of Technology and Economics (BME), Faculty of Electrical Engineering and Informatics (VIK)
1 speaker
15:50 - 16:30
The practical applications of AI
- PLENARY SESSION 4: The practical applications of AI
2 speakers
16:30 - 19:00
Long Break
19:00 - 23:00
Gala Dinner
Thursday, 27 February 2025
09:00 - 17:00
Exhibition
09:00 - 12:00
Meeting block
- Nílus Hall
Meeting duration:20 minute time slots
09:30 - 09:45
China competes with and follows US, EU stays unique
- SECTION 5: FDA workshop
1 speaker
09:30 - 09:50
Data-Driven Innovation Within Secure Frameworks
- SECTION 1: New horizontal requirements
Speaker: Dr. Enikő Molnár, Europrivacy GDPR Legal Expert, Official Partner of TAMCert Ltd.
09:30 - 10:30
Hungarian healthtech innovation ecosystem development opportunities
- SECTION 9: Hungarian healthtech innovation ecosystem development opportunities
1 speaker
09:45 - 10:00
FDA transition from the QS Regulation to the QMSR
- SECTION 5: FDA workshop
1 speaker
09:50 - 10:05
NIS2 through the eyes of an auditor
- SECTION 1: New horizontal requirements
Speaker: Marcell Zámbó, Head of SOC, Andrews IT Engineering Ltd.
10:00 - 10:30
Keys to FDA approval and medical device business in the US ~ How to succeed in the world largest medtech market ~
- SECTION 5: FDA workshop
Speaker: Takahiro Haruyama, CEO, Globizz Corporation, US
1 speaker
10:05 - 10:30
New Battery Regulation and medical devices
- SECTION 1: New horizontal requirements
Speaker: Dorottya Lőrincz, Agriculture and Environmental Field Manager, CerTrust Ltd.
1 speaker
10:30 - 10:45
Coffee Break
10:45 - 11:05
Blood, Sweat and MDR: The Raw Reality of MDR Certification
- SECTION 6: MDR transition best practice
Speaker: dr. Endre Varga, CEO, Dicomlab Dental Ltd.
10:45 - 11:45
Generating revenue from healthcare data (eHealth) - EIT Health RIS programs and market insights.
- SECTION 2: Generating revenue from healthcare data (eHealth): EIT Health RIS programs and market insights.
2 speakers
10:45 - 12:00
Difficulties in establishing startups and spin-offs
- SECTION 10: Difficulties in establishing startups and spin-offs
5 speakers
11:05 - 11:20
Challenges of PMS system
- SECTION 6: MDR transition best practice
Speaker: Árpád Zsolt Bús , division leader, SAASCO Ltd.
1 speaker
11:20 - 11:30
A Software Developer's Journey Through MDR Transition
- SECTION 6: MDR transition best practice
Speaker: Balázs Elekes Quality and Compliance Manager, Kinepict Health Ltd.
1 speaker
11:30 - 12:00
Product tracking simulation
- SECTION 6: MDR transition best practice
Speakers: Cristine Horváth-Hankó, Health Sector Manager; Róbert Magyar, Academic relations and training manager GS1 Hungary
12:00 - 13:30
Lunch Break
13:30 - 13:45
Development of Cellular-Structured Implants to Enhance Osseointegration
- SECTION 11: Mini Scientific Student Conference
Speaker: Martin Mertl, student, Budapest University of Technology and Economics (BME)
Outsourcing Software Development in the MedTech Space
- SECTION 3: Software development challenges
Speaker: Balázs Bakó, Business Development Manager, BrightHills
1 speaker
The new quality management standard for additive manufacturing technology is ISO/ASTM 52920
- SECTION 7: Additiv (3D) Manufacturing Technology
1 speaker
13:45 - 14:00
EMG-Based Muscle Activity Analysis in LabVIEW Environment
- SECTION 11: Mini Scientific Student Conference
1 speaker
Experiences and challanges related to the preparation of a standard for the manufacturing of personalized implants
- SECTION 7: Additiv (3D) Manufacturing Technology
Speaker: dr. Zsolt Pásztor, CEO, Premet Ltd.
From paper notes to cloud: a laboratory digitization journey
- SECTION 3: Software development challenges
1 speaker
14:00 - 14:15
Biocompatibility Issues of Materials Used in Additive Manufacturing
- SECTION 7: Additiv (3D) Manufacturing Technology
Speaker: Sándor Olasz, Medical Device Auditor & Field Sales Executive, SGS Hungária Kft.
1 speaker
Developing AI solutions at GE HealthCare Magyarország Kft
- SECTION 3: Software development challenges
1 speaker
Optimizing Clinical CT Device Settings in Real-World Applications
- SECTION 11: Mini Scientific Student Conference
Speakers: Dalma Tóth, student, Semmelweis University Attila Fülöp, student, Budapest University of Technology and Economics (BME)
2 speakers
14:00 - 15:00
Meeting block 2
- Nílus Hall
Meeting duration:20 minute time slots
14:15 - 14:25
Additive manufacturing for efficient development and mass production of medical devices
- SECTION 7: Additiv (3D) Manufacturing Technology
Speaker: Zoltán Fehér, Managing Director, Varinex Plc.
14:15 - 14:30
Best practices in focus: Notified body auditors and reviewers reflect on medical software auditing and cybersecurity requirements
- SECTION 3: Software development challenges
1 speaker
Predicting Complete Surgical Tumor Removal in Ovarian Cancer Patients Using Preoperative PET/CT: A Systematic Review and Meta-Analysis
- SECTION 11: Mini Scientific Student Conference
Speakers: Péter Czina, student, University of Debrecen
14:25 - 14:30
Q&A
- SECTION 7: Additiv (3D) Manufacturing Technology
14:30 - 14:45
Coffee Break
14:45 - 15:00
Challenges from design to production
- SECTION 8: Challenges from design to production
Speaker: Günter Winkler, CEO, Ottronic E-Systems GmbH
1 speaker
Combination products under Article 117
- SECTION 12: Drug-Device Combination Products
Speaker: Sara Ramió Pujol, Regulatory Expert, Alira Health
1 speaker
14:45 - 16:00
Futuristic Automated RA Process - Is it already possible today?
- SECTION 4: eRegulatory: Futuristic Automated RA Process - Is it already possible today?
3 speakers
15:00 - 15:15
Quantum Leap from Prototype to Mass Production
- SECTION 8: Challenges from design to production
1 speaker
The challenges of combination products through the eyes of a newcomer
- SECTION 12: Drug-Device Combination Products
Speaker: Eszter Solymár, Global Regulatory Lead, Gedeon Richter Plc.
1 speaker
15:15 - 15:30
The Best of 2 Worlds - Leveraging experience from Consumer Industry for the Medical Industry
- SECTION 8: Challenges from design to production
1 speaker
15:15 - 15:35
FDA QMSR alignment with ISO 13485 – practical implications for medical devices and combination products
- SECTION 12: Drug-Device Combination Products
1 speaker
15:30 - 15:45
Daily Challenges as a Contract Manufacturer of Medical Devices
- SECTION 8: Challenges from design to production
Speaker: Annamária Cseh, Customer Quality Engineer, Payer Industries Melinda Szabó, Validation Engineer, Payer Industries
15:35 - 15:55
Incident management for medical devices and combined devices
- SECTION 12: Drug-Device Combination Products
Speaker: Kornél Szerdi, Medical Device Regulatory Compliance Team Lead, Gedeon Richter Plc.
1 speaker
15:45 - 16:00
Redefining MedTech in Digital Health
- SECTION 8: Challenges from design to production
Speaker: Bipin RR, CEO, iOrbit
1 speaker