Medical Device Cybersecurity Conference Europe 2026

4^th ANNUAL EUROPEAN MEDICAL DEVICE BIOCOMPATIBILITY CONFERENCE 2026

AMSTERDAM, NETHERLANDS

From Testing to Strategic Biological Safety Across the Device Lifecycle

key information

#Biocompatibility2026

Hours of Hands-On Workshop

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Training Sessions

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Industry Speakers

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Days of Learning

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Hours of Strategic Networking

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Senior-Level Attendees

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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

WHY TAKE PART

Stay Ahead of Threats

Explore AI, machine learning, and advanced strategies reshaping healthcare cybersecurity.

Solve Real Challenges

Secure legacy devices, manage supply chain risks, and show ROI on security investments.

Make Security Strategic

Move beyond compliance toward risk-driven, business-aligned cybersecurity.

Hands-On Peer Exchange

Share insights through workshops, roundtables, and networking.

Future-Proof Your Role

Build skills in risk management, digital fluency, and strategic influence.

Impact Beyond the Agenda

Discuss emerging threats and real-world innovations shaping the field.

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

The topics are well defined & relevant.

– Team Manager – Active Medical Devices

I feel that I learned a lot about the current environment in compliance around the SaMD space. I am excited to go back & incorporate some agile principles into my team

– Regulatory Affairs Specialist

This was exceptional! A massive amount of helpful & directly relevant information. Best conference ever, will be back!

– Senior Supervisor Quality Engineering Software

Good content & enjoy smaller groups - I think this promotes networking more

– Senior Product Manager, Software

The topics, speakers, and participants were extremely relevant to the title of the conference. The knowledge received from the conference is extremely helpful

– Embedded Software Integration Engineer

Content was great, very applicable to this rapidly changing area of our industry

– Principal Specialist, Division Quality

Good knowledge transfer, good idea to take back to my company. Great networking opportunities

– Principal Software Engineer

A great event to network with individuals and a brilliant way to increase awareness of cybersecurity approaches across the medical device world

– Digital Health Security Lead

It was a fantastic opportunity to speak with experts who are deeply immersed in this exciting subject. The awareness of the cybersecurity topic was impressive!

– Project Manager IVD Medical Device Testing

I liked the detailed and practical topics, such as building a threat model.

– AI Project Manager & Certification Project Manager

Fantastic presentations, interactive workshops and opportunities to meet new people. Thank you for this event.

– Product Manager

There was a lot of knowledge in the room from very experienced practitioners, which gave real-life, actionable advice

– Senior Manager

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