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Date: September 29th-30th
Key poins:
Welcome to the Biocompatibility and Material Safety & Contaminant Control 2025 Conference!
We are delighted to host this premier event in Barcelona, Spain, bringing together leading experts, researchers, and industry pioneers dedicated to advancing biocompatibility testing, material safety, and contaminant control in medical devices.
Over the next two days, you’ll engage in insightful discussions, explore innovative solutions, and connect with key stakeholders shaping the future of medical device safety. With a dynamic agenda covering regulatory updates, risk-based approaches, extractables and leachables (E&L), and the latest advancements in material science, this event offers an unparalleled opportunity to gain actionable insights and foster strategic collaborations.
We look forward to meaningful conversations, cutting-edge research, and impactful networking as we collectively drive innovation and compliance in the medical device industry!
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.
The Biocompatibility and Material Safety & Contaminant Control 2025 Conference is designed for professionals involved in medical device safety, compliance, and material science. This event is essential for:
Join key decision-makers, scientists, and innovators at this leading conference to stay ahead in the ever-evolving world of medical device safety, biocompatibility, and contaminant control!
Welcome to the Biocompatibility and Material Safety & Contaminant Control 2025 Conference in the vibrant city of Barcelona, Spain!
We are excited to bring together industry leaders, regulatory experts, and innovators for two days of in-depth discussions and knowledge sharing. Whether you are returning or joining us for the first time, this conference provides a unique opportunity to explore the latest advancements in biocompatibility testing, material safety, and contaminant control for medical devices.
Throughout the event, we will delve into global regulatory frameworks, including updates to ISO 10993 standards and evolving compliance requirements under FDA and EU MDR. Discussions will address risk-based approaches to biocompatibility, the integration of chemical characterization in material assessments, and the challenges of sensitization, irritation, and biodegradation testing.
Attendees will gain valuable insights into extractables & leachables (E&L) testing, exploring how analytical techniques such as mass spectrometry are revolutionizing contaminant detection. Additionally, the agenda features case studies on post-market surveillance, the impact of manufacturing processes on material safety, and the latest research into alternative and sustainable polymers.
This conference is a key platform for professionals committed to advancing medical device safety and efficacy. Engage with leading experts, exchange best practices, and collaborate on innovative solutions that will shape the future of biocompatibility and contaminant control. We look forward to insightful discussions, meaningful connections, and pioneering advancements that will drive medical technology forward!
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Biocompatibility and Material Safety & Contaminant Control 2025 Conference
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 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 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
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.
