Understanding Biological Evaluation of Medical Devices
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).
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&A, Moderated by Rose-Marie Jenvert, Veranex
17:30 Networking, Drinks and Snacks