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2nd Annual Medical Device Biocompatibility & Risk-Safety Summit

2nd Annual Medical Device Biocompatibility & Risk-Safety Summit

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  • 19-20 March 2026
  • Berlin, Germany

The Medical Device Biocompatibility & Safety Summit 2026 event brings together industry leaders, regulatory experts, and scientists to explore the latest innovations and challenges in ensuring the safety and compliance of pharmaceuticals, medical devices, and packaging. Attendees will gain insights into cutting-edge testing methods, regulatory updates, risk management strategies, and emerging trends in materials science, biocompatibility, and E&L analysis. This forum provides a platform for collaboration, knowledge sharing, and addressing critical safety and regulatory issues in the healthcare industry.

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About the Conference

Manufacturer 1299 EUR
- 2 days Conference participation
- Coffee breaks, beverages, meals and refreshments at the conference site.
- Documentation package.
- Gala Dinner from 19:00 till 21.00.

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Service Provider 1799 EUR
- 2 days Conference participation
- Coffee breaks, beverages, meals and refreshments at the conference site.
- Documentation package.
-Gala Dinner from 19:00 till 21.00.

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Speaker pack 1999 EUR
- 30 minutes speaking slot + 10 minutes Q&A
- 2 days Conference participation
- Coffee breaks, beverages, meals and refreshments at the conference site.
- Documentation package.
- Gala Dinner from 19:00 till 21.00.

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Key topics on this year’s Mon Bien events Biocompatibility agenda include

1. Advances in Biocompatibility Testing
  • Next-generation biocompatibility assessment techniques
  • 3D tissue models and in vitro systems for predicting biological response.
  • Integration of AI and machine learning in biocompatibility analysis.
  • Personalized medicine and its impact on biocompatibility standards.
  • Novel toxicology testing methods, reducing animal testing.
  • Predictive toxicology: Using omics and data-driven approaches to predict toxicity.
  • Development of new toxicity biomarkers for early detection.
  • Toxicological risk assessments for combination products and nanomaterials.
  • Updated methodologies for E&L testing in pharmaceutical packaging and medical devices.
  • Regulatory challenges for E&L in global markets (FDA, EMA, ISO updates).
  • E&L in biologics and cell-based therapies: Addressing new challenges.
  • Case studies on complex materials and advanced packaging systems.
  • Overview of recent global regulatory changes (FDA, EMA, ISO 10993, ICH Q3E).
  • Best practices for navigating evolving E&L regulations.
  • Bridging the gap between biocompatibility and regulatory requirements.
  • Strategies for compliance with evolving environmental and chemical regulations (e.g., REACH, EU MDR).
  • Innovations in materials science: New biocompatible materials for medical devices and drug delivery systems.
  • Role of polymers, coatings, and composites in enhancing biocompatibility.
  • Biocompatibility of sustainable and eco-friendly materials.
  • Risk-based approaches to biocompatibility and toxicology evaluation.
  • Holistic safety evaluation: Balancing biocompatibility, toxicology, and E&L risks.
  • Integrating risk management frameworks in product development cycles.
  • E&L considerations for eco-friendly and biodegradable packaging materials.
  • Challenges and solutions for sustainable packaging in pharmaceuticals.
  • Long-term impact of leachables in reusable and multi-use medical devices.
  • Novel analytical technologies for detecting E&L in low concentrations.
  • Automation and miniaturization in E&L testing workflows.
  • High-throughput screening methods for complex leachables.
  • Real-world case studies on E&L testing in complex products.
  • Success stories and lessons learned from biocompatibility failures and recalls.
  • Interactive panels on troubleshooting and optimizing E&L processes.
  • The role of big data and digital transformation in biocompatibility and toxicology.
  • Predicting future trends in biomaterials and their biocompatibility.
  • Collaborative approaches to tackle global biocompatibility and toxicology challenges.

What to expect in Mon Bien events Biocompatibility Summit 2026?

During the two days of the Medical Device Biocompatibility & Safety Summit 2026,
Mon Bien willprovide an exclusive, focused environment where speakers and delegates engage deeply on industry-relevant topics. Our sessions, built around carefully selected case studies based on extensive market research, ensure practical insights and real-world applications. With interactive panel discussions and Q&A sessions, you’ll have the opportunity to get your questions answered directly by experts. Delegates, Speakers & Exhibitors  will leave with valuable new connections, enhanced knowledge, and actionable strategies to drive their professional growth.

Speakers

Aleš Martinovský

Executive Director

Porta Medica

Veronika Valdová

Consultant

Insife

Laura Quirke

Senior Specialist, Biocompatibility

Convatec

Dr. Alexander Laubach

Head of Business Development Medical Technologies & Biocompatibility

Hohenstein Laboratories GmbH & Co. KG

Crystal D`Silva

Associate Director, Material Characterization and Assessment

Baxter International Inc.

Daniele Lioi

Medical Device Senior Consultant and Business Unit Manager

Eurofins Regulatory & Consultancy Services

Wolfgang Rudy

Director: Biocompatibility
of Medical
Devices

Tentamus Pharma & Med

Nebojsa Serafimovic

Assessor for Clinical Investigations

Austrian Federal Office for Safety in Health Care

Frank De Smedt

Founder/Owner

DyFrNd

Dr. Alina Martirosyan

Senior Scientific Manager Toxicology

B.Braun Melsungen AG

Tino Otte

Director of Business Development

Intertek (Schweiz) AG

Petr Brat’ka

Head of Preclinical Evaluation Department, Project Leadership Manager, Product Reviewer Center for Medical Device Certification

Czech Metrology Institute

Dr. Yuriy Svartsov

Global Business development manager

Intertek, Switzerland

Sponsorship Opportunities

Lead the Conversation. Own the Stage.

Our tailored sponsorship packages offer prime visibility, thought leadership opportunities, and direct access to decision-makers across the financial ecosystem. Let us help you put your brand in the spotlight.

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Venue for Innovation & Insight!

  • Berlin, Germany
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  • 19-20 March 2026
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Target Market and Audience

  • Academics and Researchers
  • Healthcare Professionals: Physicians, surgeons, and other medical practitioners
  • Post-Market Surveillance Experts
  • Consultants and Industry Experts in the field of medical device biocompatibility and toxicology
  • Risk Management Specialists
  • Biocompatibility Specialists: Experts who assess the compatibility of medical devices with biological systems and tissues
  • Medical Device Manufacturers
  • Toxicologists
  • Effects of medical devices and their components
  • Regulatory Affairs Professionals
  • Quality Control/Quality Assurance Professionals
  • R&D Scientists and Engineers
  • Testing Laboratories

Who should attend Mon Bien events Biocompatibility Summit 2026?

Pharmaceutical and Biotech Companies
  • Roles: R&D Scientists, Toxicologists, QA/QC Specialists, Regulatory Affairs.
  • Relevance: Ensure safety, efficacy, and regulatory compliance of drug products, including E&L and biocompatibility testing.
  • Roles: Product Engineers, Material Scientists, Compliance Officers.
  • Relevance: Focus on biocompatibility and safety of devices, keeping pace with regulatory changes.
  • Roles: Packaging Engineers, Material Scientists, Chemical Engineers.
  • Relevance: Ensure packaging materials meet safety and compliance standards for E&L.
  • Roles: E&L Testing Experts, Toxicologists, Chemists.
  • Relevance: Provide specialized testing and compliance services for pharmaceutical and device companies.
  • Roles: Inspectors, Policy Makers, Compliance Experts.
  • Relevance: Provide insights on guidelines, compliance, and safety standards.
  • Roles: Analytical Chemists, Lab Managers, E&L Scientists.
  • Relevance: Conduct E&L testing and biocompatibility assessments using advanced methodologies.
  • Roles: Product Safety Managers, Testing Experts.
  • Relevance: Ensure long-term safety of packaging and materials in healthcare products.
  • Roles: Professors, Researchers, PhD Students.
  • Relevance: Contribute to research advancements in biomaterials, toxicology, and E&L.
  • Roles: Regulatory Consultants, E&L Specialists.
  • Relevance: Offer expertise in compliance and risk mitigation strategies.
  • Roles: Representatives from ISO, ASTM, etc.
  • Relevance: Shape and update industry standards for biocompatibility and E&L.

Are you an expert, visionary, or thought leader in your field?

Why Speak at Our Events?

Our conferences bring together top-level professionals from across the globe – and we’re always looking for powerful voices to shape the conversation.

  • Position yourself as a leader in your industry
  • Share your insights and inspire a high-level audience
  • Strengthen your personal and company brand visibility
  • Connect with influential peers, decision-makers, and potential partners

What It Involves:

  • A 30–45-minute keynote, panel, or case study presentation
  • Premium networking opportunities in a closed-door, executive setting
  • A chance to engage with an international audience and elevate your influence
  • Connect with influential peers, decision-makers, and potential partners
Become a Sponsor
Become a Speaker

Your Venue for Innovation & Insight

Berlin, Germany

Hosting the 2nd Annual Medical Device Biocompatibility & Risk-Safety Summit in Berlin reflects the city’s role as a leading center for medical research, innovation, and regulatory dialogue. Berlin is home to world-class universities, renowned hospitals, and a vibrant life sciences industry, making it the ideal setting to explore the future of medical device safety and compliance

With its central European location and excellent international connectivity, Berlin offers easy access for participants from across Europe, the Middle East, Asia, and the Americas. Beyond the sessions, attendees will enjoy a city known for its history, culture, and dynamic business environment, providing the perfect backdrop for high-level learning, networking, and collaboration.

  • 2nd Annual Medical Device Biocompatibility & Risk-Safety Summit
  • Berlin, Germany
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