Medical device manufacturers must conduct biological (biocompatibility) evaluations for their medical devices to demonstrate biological safety not only when placing a medical device on the market, but throughout its complete lifecycle. Do you have a biological evaluation strategy for ensuring that your medical device product are safe for its intended use?
Join us at the next Medicon Valley MedTech Network meeting to learn more about the general principles for biological safety evaluation, what to consider and why, and how biological evaluations are impacted by the upcoming changes in ISO 10993-1. Invited companies will share their experience and challenges they encountered during the biological evaluation of their medical device(s).
Date: Thursday, 2nd October 2025
Time: 14:00 – 18:00
Venue: Level Two, The Loop, Science Village, Rydbergs torg 4, Lund – Meeting room Impact
Program
| 14.00 | Registration and Networking |
| 14:30 | Welcome Katrine Brems Olsen, Head of Networks, Medicon Valley Alliance |
| 14:35 | Introduction to Biological Evaluation; a risk-based approach and not just a checklist Monica Grekula, Sr Director Scientific Affairs, Veranex |
| 15:05 | Biological Evaluation of Medical Devices from a Manufactures perspective – process and challenges Maria Ahlm Mattebjerg, Principal Biosafety Specialist, Coloplast |
| 15:25 | Biological Evaluation of Resorbable Synthetic Bone Graft Substitutes- Strategy and hurdles Johanna Dennbo, Biological Safety & Material Specialist, Bonesupport |
| 15:45 | Coffee Break |
| 16:15 | Balancing Safety, Cost and Speed: A pragmatic approaches to biocompatibility in Medical Device development Jakob Ohm Eriksen, CCO, Neocare Nordic |
| 16:35 | Redefining Biocompatibility Testing: The Role of In Vitro Models in Product Development and regulatory submissons Andy Forreryd, Scientific Liaison Manager, Senzagen |
| 16:55 | Panel Discussion and Q&R Moderated by Rose-Marie Jenvert, Veranex |
| 17:30 | Networking, Drinks and Snacks |
| 18:00 | End of meeting |
Speakers
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Monica Grekula serves as Senior Director at Veranex Sweden AB in Stockholm, where she leads the biological safety and toxicology team with over 25 years of expertise in the medical device industry. She specializes in biological evaluations across all development phases from a global perspective, covering Class I-III devices and combination products, with comprehensive experience working with various notified bodies and national regulatory authorities. Monica holds a Master of Science in Pharmacy and a Master of Science in Applied Toxicology, and is certified as a European Registered Toxicologist (ERT). |
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Maria Mattebjerg is a Principal Biosafety Specialist at Coloplast and a member of the Danish Standard committee S-258 for standards within biocompatibility and clinical documentation. Maria has more than 10 years of experience within the field of Biological Evaluation of medical devices and has performed such evaluations for a variety of different products. Maria has extensive experience in implementation of ISO 10993 requirements from a manufacture’s perspective. |
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Johanna Dennbo is a Senior Biological Safety & Material Specialist at BONESUPPORT AB with 10 years+ experience in biocompatibility evaluations and toxicology. She has experience from medical device Class I-III pre-clinical safety evaluations, ranging from dialysis devices and medical beds to medical devices incorporating a medicinal product. She holds an MSc in Molecular Biology/Toxicology/Immunology. |
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Jakob Ohm Eriksen, Biologist, is a Co-founder and CMO/CIO/COO at NeoCare Nordic, specializing in accelerating MedTech innovation from concept to market. With 25+ years in diagnostics, product strategy, and clinical affairs, he blends scientific expertise with pragmatic execution to deliver faster, compliant, and market-ready solutions. |
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Andy Forreryd has a PhD in applied immunology and many years of experience working with in vitro assay development. He is a member of the OECD expert group for respiratory sensitization and the ISO WG8 for skin sensitization testing of Medical Devices. He is co-developer of the GARDskin assay (OECD TG 442E) for assessment of chemical sensitizers and is currently employed by SenzaGen as a Scientific Liaison Manager and engages in collaborations with industry leaders and academia to investigate novel applications for NAM-based sensitization testing, with the aim to replace the need for animal studies. |
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Rose-Marie Jenvert has over 20 years of experience within the medical device, pharma and biotechnology industry, and is currently working as Biocompatibility Manager at Veranex. 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 10+ years 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. |
Deadline for registration is 30th September
The Network
The MVA MedTech Network is a professional network for Medicon Valley Alliance members from industry, academia and the health care sector with an interest in the MedTech field. Joining the network is free of charge but is limited to Medicon Valley Alliance members. However, non-member organizations and companies are welcome to attend one network event to evaluate if joining the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically allow you to join the network.
For more information please contact Katrine Brems Olsen kbo@mva.org
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