Biocompatibility Testing In Medical Devices 2024 Conference

Place: Munich, Germany

Date: 21th-22th of March 2024

Key poins:

  1.  Understanding Regulatory Compliance
  2. Risk Assessment Principles
  3. Materials Selection Strategies
  4. Toxicology Assessment
  5. In Vitro vs. In Vivo Testing
  6. Implementing Biocompatibility in Clinical Trials
  7. Post-Market Surveillance
  8. Combination Products Challenges
  9. Ethical Considerations
  10. Global Harmonization

Event Sponsors

European Biomedical Institute (EBI) is providing comprehensive biocompatibility and chemistry testing of medical devices according to ISO 10993 in-house. 

EBI is:

  • ISO 17025 accredited
  • GLP certified
  • US FDA 21CFR58 compliant

 

Our laboratories are located in Poland and the United Kingdom. 

EBI services include:

  • chemical characterization, extractable and leachable (E&L)
  • complete ISO 10993 biocompatibility (in vitro and in vivo)
  • microbiology and sterility
  • cleaning, disinfection and sterilization validations
  • package validation
  • toxicology

Keynote Sponsor

Keynote Sponsor

Silver Sponsor

Event Sponsor

Welcome to the Biocompatibility Testing In Medical Devices 2024 Conference, scheduled for March 21th-22th, 2024. We are excited to invite you to this prestigious gathering of industry experts, thought leaders, and innovators from across the globe.

Our conference serves as a vital platform for exploring the latest challenges, novel applications, innovations, and trends within the Medical Devices Industry. It is an opportunity to engage in stimulating discussions, gain fresh insights, and establish valuable connections.

Over these two days, we aim to foster collaboration and empower progress. Your presence here is integral to our mission of shaping the future of biocompatibility testing. Together, we will advance the standards of excellence in the field.

Thank you for joining us on this transformative journey. Welcome to the Biocompatibility Testing In Medical Devices 2024 Conference, where knowledge meets innovation, and where the future is being forged.

Our speakers

Biocompatibility Specialist

Biocompatibility Specialist

Biocompatibility Specialist

R&D Engineer Medical Devices

Head of Material Development & Biocompatibility

The conference contains

14 speakers

Business Lunches & Evening Reception

10+ networking hours

Panel discussion

Workshop

Expected Speakers from:

  • Medtronic: A global leader in medical technology, Medtronic has extensive experience in biocompatibility testing across a wide range of medical devices.

  • Johnson & Johnson Medical Devices Companies: With a diverse portfolio of medical devices, J&J can provide insights into biocompatibility challenges and solutions.

  • BD (Becton, Dickinson and Company): BD specializes in medical technology and can share expertise in materials selection and regulatory compliance.

  • Abbott Laboratories: Known for innovative medical devices, Abbott can discuss its approaches to biocompatibility and safety testing.

  • Boston Scientific: A leading manufacturer of medical devices, Boston Scientific can offer insights into biocompatibility in the context of cardiovascular and other devices.

  • Siemens Healthineers: As a leader in diagnostic and imaging equipment, Siemens can provide perspectives on biocompatibility considerations for healthcare technology.

  • Philips Healthcare: Philips’ expertise in healthcare technology and equipment makes them a valuable source of knowledge on biocompatibility testing.

  • 3M Healthcare: 3M’s diverse healthcare product range can contribute insights into materials selection and safety assessment.

     

Who should attend:

  • Medical Device Manufacturers
  • Quality Assurance and Control Personnel
  • Biomedical Engineers
  • Toxicologists
  • Materials Scientists
  • Clinical Researchers and Trial Managers
  • Biotechnology Professionals
  • Pharmaceutical Professionals
  • Ethical Review Boards and Animal Welfare Experts
  • Environmental Impact Specialists
  • Academics and Researchers
  • Government Regulatory Authorities
  • Healthcare Professionals
  • Investors and Venture Capitalists
  • Patient Advocacy Groups
  • Consultants and Industry Experts
  • Legal and Compliance Experts

Benefits of attendance:

  • Meet new connections in groups or one-on-one;
  • Further develop and strengthen your network;
  • Expand your knowledge,
  • Stay up to date
  • Grow your personal brand
  • Enjoy, create memories and have fun

About Biocompatibility Testing in Medical Devices Conference:

Welcome to the Biocompatibility Testing in Medical Devices Conference, where industry leaders, regulatory experts, and innovators come together to explore the critical nexus of science, regulation, and patient safety.

In the ever-evolving landscape of medical devices, ensuring biocompatibility remains paramount. Our conference is designed to provide a comprehensive platform for professionals and organizations engaged in the development, manufacturing, and regulation of medical devices.

This dynamic event delves into the core principles and practical applications of biocompatibility testing, offering invaluable insights and strategies to navigate the complex regulatory environment. From ISO standards compliance to toxicology evaluations, materials selection, and post-market surveillance, our agenda covers the entire spectrum of biocompatibility testing.

Expect engaging presentations, real-world case studies, and interactive discussions led by experts from renowned companies, regulatory bodies, and academic institutions. Learn from industry giants like Medtronic, Johnson & Johnson, and BD, who have paved the way in biocompatibility excellence.

Whether you are a seasoned professional seeking the latest updates or a newcomer looking to grasp the fundamentals, this conference promises a rich exchange of knowledge. Engage with thought leaders, network with peers, and gain the tools necessary to drive innovation while prioritizing patient safety.

Join us for an immersive experience at the forefront of biocompatibility testing. Together, we advance the standards of excellence that shape the future of medical devices.

Munich: Bridging Tradition and Innovation

Welcome to Munich, the esteemed host city of our Biocompatibility Testing in Medical Devices Conference. Munich embodies a captivating blend of historical richness and cutting-edge progress.

Munich is a beacon of intellectual brilliance, boasting world-class universities and research institutions that captivate the minds of global scholars and innovators.

Its architectural grandeur is awe-inspiring, with regal castles, opulent palaces, and ornate cathedrals that bear witness to centuries of cultural achievement.

Culturally, Munich is nothing short of intimidating, home to prestigious museums, opera houses, galleries, and theaters that push the boundaries of human creativity.

As a global innovation hub, Munich thrives with technology, research, and industry leaders converging to set an exemplary standard.

While advancing into the future, Munich remains deeply rooted in Bavarian traditions, offering a glimpse of a culture that proudly endures.

With global influence and cosmopolitan diversity, Munich commands respect in international discourse.

Our choice of Munich as the conference venue reflects our commitment to excellence. Join us for an unmatched conference experience where innovation and tradition harmoniously collide. Munich awaits your immersion in a dynamic intellectual milieu.

What our clients say about us

"I'd like to express my sincere appreciation for the exceptional organization of the conference. The topics discussed were not only captivating but also delved into cutting-edge techniques in the field of 3D cell culture and 3D microscopy. The speakers, true experts in their domains, added immense value to the event. Thank you for such an enriching experience."
Charles University

Media Partners

Rose-Marie Jenvert

Rose-Marie Jenvert has over 20 years of experience within the medical device, pharma and biotechnology industry, and is currently working as Biocompatibility Specialist at Veranex, located in Lund Sweden. Rose-Marie is an experienced method developer of in vitro methods and holds a MSc in Molecular Biology and a PhD in Cell Biology. She has experience in performing biological evaluations of medical devices and has previously worked as study director for biocompatibility studies, setting up testing strategies and coordinating biological and chemical testing. She also has hands-on experience of testing different materials and medical devices.

Rose-Marie is actively working as an expert in ISO/TC194 WG8 with updating of the standards for skin sensitization and skin irritation (ISO 10993-10 and -23), and is also involved in the work of WG5, the standard for cytotoxicity.

Michael Burkard

Michael works as a Biocompatibility Specialist at Sonova AG, focusing on evaluating and implementing biocompatibility testing strategies for medical devices and materials. Furthermore, he has experience as a project manager in Product Stewardship, ensuring safety and regulatory compliance in the chemical sector. Since his Ph.D. in environmental toxicology, Michael consistently emphasized the development and application of innovative in vitro methods, such as the development of novel cell lines for toxicity screening. He will share practical insights and present case studies about his experience using in vitro sensitization methods for medical devices.

Jan Wirsching

Jan Wirsching has many years of experience in the medical device industry working in the field of biocompatibility and material compliance, and is currently working at Maquet Cardiopulmonary GmbH, a Getinge Company. Jan holds degrees in Molecular Medicine and Toxicology. He has experience in performing biological evaluations, toxicological risk assessments and material compliance evaluations for a wide range of devices, including combination products. Jan Wirsching is actively working as an expert in the development of a guideline on characterizing and assessing nanomaterials in medical devices and in vitro diagnostics (VDI 5709).

Theme: Complexity of Combination Products: Drug Device Interactions

– What are drug device interactions and how to investigate them?

– How do drug device interactions influence the biological risk assessment?

– Case Study: Biological risk assessment of a Heparin/Albumin-coated combination product

Klaudia Krzeszewska

Klaudia Krzeszewska, biomedical engineer by training, with special focus on biomaterials. During past 4 years in medical device industry in Regulatory Affairs and Research & Development, she worked with catheters, biodegradable stents and combination products. Interested in circular economy and sustainable approach to medical devices‘ development and manufacturing.

Ira Sharma Sankhayan

Ira has 18 yrs of experience in the industry. Having a bachelor in electronics and masters in microelectronics, she started her career as a DnD engineer. Since 2011, as a Global commodity role in GEHC, she stepped into the world of regulatory compliance for medical devices. Since, then she has been a part of more than 100 projects, leading the roles as a CTO, Head of QA RA, PRRC and Design transfer leader. Yallow life science started in September 2020, a consultancy firm, both with DnD and QA RA, where Ira Led the QA RA team and built it. Since then, the company has grown and has led many projects in combination. Presently She is the CEO of the company.

Fabian Kriegel

Fabian Kriegel is currently Head of Material Development and Biocompatibility at Carl Zeiss Meditec AG, where he leads a dynamic team focused on the development of biocompatible materials, particularly for ophthalmic applications. Together with his dedicated team, Fabian ensures the seamless implementation of testing strategies in accordance with international standards for safety and efficacy. His expertise also extends to guiding projects through the complex processes of international regulatory approval, facilitating the acceptance of medical devices on a global scale.

Prior to his current role, Fabian held positions such as GLP Study Director and Genetic Toxicology Laboratory Manager in the pharmaceutical industry. Academically, Fabian has contributed to various research areas such as nanomaterial toxicity, analytical chemistry and computational biology. In addition, he is recognized as a European Registered Toxicologist and an active member of various toxicology societies.

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