4th ANNUAL EUROPEAN MEDICAL DEVICE BIOCOMPATIBILITY CONFERENCE 2026
AMSTERDAM, NETHERLANDS
From Testing to Strategic Biological Safety Across the Device Lifecycle
key information
- NH Amsterdam Schiphol Airport Hotel, Netherlands
- 15th – 17st September 2026
#Biocompatibility2026
Conference Insights
Be part of a focused three-day experience where biocompatibility leaders and regulatory experts come together to strengthen strategies, drive innovation, and navigate evolving requirements.
What to Expect:
- Hands-on workshops with practical, execution-led content
- Clear focus on risk-based approaches aligned with ISO 10993
- Real-world case studies and actionable insights
- Expert-led discussions on EU MDR and notified body expectations
- Peer exchange with industry leaders and regulators
3 DAYS OF INSIGHTS & INNOVATION
PRE-CONFERENCE WORKSHOP DAY
IMMERSIVE WORKSHOPS
STRATEGIC TRACK
WORKSHOP A:
- Implementing the New ISO 10993 Biological Evaluation Framework
- Interactive exercise on Defend your BEP – a live mock regulatory review
WORKSHOP B:
- Chemical Characterization & Toxicological Risk Assessment Masterclass
CONFERENCE DAY 1
CORE BIOCOMPATIBILITY & REGULATORY STRATEGY
- End-to-end biocompatibility strategy—integrating chemical characterization, toxicological risk assessment, and safety evaluation, while addressing combination products, material/process changes, and sterilization impacts with minimal re-testing
- Case study on Building a defensible BEP under ISO 10993-1
- Notified Body Panel discussion: Approval-ready biocompatibility files
- Roundtables’ discussion: Risk-based approaches, stronger evidence alignment, and effective regulatory response strategies
CONFERENCE DAY 2
ADVANCED STRATEGY, INNOVATION & LCM
- Global biocompatibility strategy—aligning notified body and FDA expectations, leveraging AI and novel materials, and strengthening post-market monitoring with integrated clinical evidence
- Fireside chat: Are we over-testing?
Our Industry Specialists
Somesh Rasal
Razvan Venter
Maroun Habib
Dr. Xenofon Kontargyris
Ben Kokx
Alexander Jung
Jorg Marzel
David McGettrick
Andre van Schalkwyk
Shaloo Sood Kuthiala
Jorge Wallace Ruiz
Lasse Janz
Attila Szabo
Barry Curran
Mark E. Schreiber
Alf Ludwig
Robin Burgess
Luzie Cosanne
Ole Buttner
Andrea Fasano
Dr. Natallia Karniyevich
Dmitry Raidman
Zahra Khani
Seth Carmody
WHY TAKE PART
Move beyond checklist testing to science-based justification
Understand real notified body expectations and deficiencies
Apply chemical characterization effectively instead of over-testing
Benchmark strategies with industry peers facing similar MDR challenges
Strengthen submissions and improve approval success rates
KEY TAKEAWAYS
Master risk-based biocompatibility strategies
Gain clarity on how to align testing with regulatory expectations while minimizing unnecessary studies.
Build robust Biological Evaluation Plans (BEPs)
Learn how strong, well-justified BEPs can accelerate approvals and reduce costly delays.
Unlock the power of chemical characterization
Discover when and how it can effectively replace traditional biological testing.
Stay ahead of notified body expectations
Understand evolving requirements and address potential gaps early in the process.
Strengthen toxicological risk assessments
Develop confident, science-driven justifications that support regulatory decision-making.
Explore AI and predictive toxicology innovations
See how emerging tools are transforming biological safety evaluations.
Moments Captured
Take a glimpse into the highlights of our conferences, where ideas come to life and connections are made
Our Testimonials
Another very stimulating exchange - together we can achieve more!
– Director, Biological Evaluation, Geistlich
An inspiring and well-organized conference that offered valuable insights, meaningful connections, and fresh perspectives to take back to my daily work
– Toxicologist spec. Biocompatibility, Karl Storz SE & Co KG
It was very informative and insightful
– Research Principal Scientist, ZIMMER BIOMET
Liked the diversity of topics and the shared case studies!
– Principal Toxicologist, NELSON LABS
Great conference for learning!
– Manager/Global Lead | Extractable and Leachable (E&L) Testing, SGS
This conference provided opportunities to meet other participants and have a valuable exchange
– Associate Scientist, BAXTER
YOUR ALL-IN-ONE GUIDE TO THE EVENT
Get the full scoop on what’s in store!
Explore the event overview and dive into the agenda for the 4TH ANNUAL EUROPEAN MEDICAL DEVICE BIOCOMPATIBILITY CONFERENCE 2026—your gateway to 3 days of strategy, science, and innovation.
COLLOCATE WITH US/EUROPE
- 20th - 22nd October 2026
- Boston, MA, US
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