BIOMEDICAL AI COMPLIANCE & SAFETY SUMMIT

Two Days of Insight & InnovationConnect with biomedical, AI, and regulatory leaders shaping the future of compliant and safe healthcare technologies.
This is your opportunity to advance your career and deepen your expertise in responsible AI, patient safety, and evolving global regulations.

Prague

December 4 - 5, 2025

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About the conference

December 4 - 5, 2025

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BIOMEDICAL AI COMPLIANCE
& SAFETY SUMMIT

We are thrilled to invite you to the Biomedical AI Compliance & Safety Summit,
a premier global event dedicated to the intersection of artificial intelligence, compliance, and safety in healthcare. Set in the vibrant city of Prague, Czech Republic, this two-day summit provides the flexibility to attend either in person or virtually. Join industry leaders, regulatory professionals, and innovators as we explore the future of AI-driven medical technologies and ensure their safe, compliant integration into healthcare systems.

Prague

Event location

Speakers

Giorgia Romeo
Active Medical Devices Team Manager
SGS

Giorgia Romeo is a biomedical engineer with extensive experience in software design and development who began her career in IT in 2005 before transitioning to medical device manufacturing in 2009. She has contributed to developing various software solutions including optical systems for spine measurement, spirometer and ECG software, and endoscopic modules, while also working as an MDR consultant from 2017-2019 helping manufacturers transition technical files for devices ranging from insulin pumps to robotic surgical systems. After joining BSI in 2020 as a technical specialist overseeing certification activities, she now serves as team manager of the Active Medical Devices Team at SGS Notified Body since February 2024, where she manages product assessors and conducts MDR and UKCA assessments.
Maciej Piotrowski
Director and Chief Solution Architect, AI for Healthcare at IQVIA, a Human Data Science Company
IQVIA

Maciej Piotrowski is a seasoned Solution Architect at IQVIA - The Human Data Science Company, where he serves as director of architecture responsible for defining technology strategy for Health Data Transformation, Analytics and AI Products within the Applied AI Science organization. He specializes in transforming health data ecosystems to enable smarter care delivery, leading strategic initiatives that harness AI to improve clinical decision-making, streamline patient data interoperability, and accelerate research insights through scalable data platforms and privacy-preserving analytics. Throughout his career, Maciej has held senior technical positions including Enterprise Architect in healthcare, Chief Technologist in financial services, and leadership roles in global services delivery, with his expertise consistently focused on Architecture, Artificial Intelligence, and Data Analytics while maintaining a commitment to ethical AI and human-centered healthcare solutions.
Agata Krasoń
Senior Clinical & Imaging
Data Scientist
Roche

Agata Krasoń, PhD, is a biomedical data scientist specializing in AI-driven clinical imaging and oncology research at Roche, where she develops data products supporting biomarker discovery, patient stratification and trial optimization. With a PhD in Biomedical Engineering and over a decade of experience across pharma, medtech and diagnostics, she integrates multimodal data—from medical images to real-world evidence—to inform evidence-based decision-making in early clinical development while enabling collaborative, data-centric innovation across global research teams.

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Leverage cutting-edge technologies to optimize biomedical research and development, enhance data traceability, and drive innovation in personalized medicine and sustainable healthcare.

Practical Skills

Network with fellow experts, industry colleagues, and representatives from AI, Pharma and BioMed companies.

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KEY POINTS:

We RECOMMEND
to participate:

2 days

from 8:00 AM

December 4 - 5

PRAGUE

Analytical techniques for E&L testing
Strategies for material selection and risk management
Case studies on industry-leading breakthroughs
MDR Impact on Risk Management and

Clinical Evaluations

Innovations in Biocompatibility

Testing and Toxicological Evaluation

Executives & Decision-Makers in MedTech & Pharma
Business Development Managers
Innovation Managers
Product Safety & Compliance Leaders
Regulatory Agency Representatives

(FDA, EMA, Notified Bodies, etc.)

ISO & Standardization Experts

AI in Regulatory Compliance (FDA, EMA, MDR, IVDR)
AI-Powered Risk Assessment & Toxicology Models
AI for Biocompatibility & Extractables/Leachables Testing

Data Privacy & Security (GDPR, HIPAA)
AI Model Validation & Bias Detection
Ethical Considerations & Governance in Biomedical AI

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PRE-REGISTRATION till 30/5

2 Networking Lunches

Speakers' Presentations

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Video Recording

Speaking Slot 30 Min

2 Networking Lunches

*Post-event materials will be shared with you within 10 business days of the conference closing

Recordings

2-day In-Person Participation

Speakers' Presentations

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