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SUMMARY:Webinar: Regulatory updates & industry perspectives on NAMs for Medical Device Safety
DESCRIPTION:Join us for an insightful webinar on the evolving role of New Approach Methodologies (NAMs) in regulatory biological safety assessments and how they can be used to help develop safe materials in the pre-regulatory space. With shifting standards and increasing adoption of NAMs\, understanding their impact is more critical than ever. \nIn this webinar\, Dr Andy Forreryd\, our expert in in vitro skin sensitization and active member of ISO/TC 194/WG 8\, will break down the latest regulatory updates on ISO 10993-10 and present new data from the GARD®skin Medical Device pre-validation study—a key milestone toward regulatory acceptance. \nYou will also hear from Dr Karla Lienau\, Biological Safety Specialist and Research Engineer at Sonova\, a global leader in Medical Devices\, on how NAMs are shaping product development\, ensuring compliance\, and accelerating innovation. \n \nKey takeaways\n\nRegulatory insights: Understand the latest developments in ISO 10993-10 and the role of in vitro methods.\nGARD® advancements: Learn how this technology supports skin sensitization testing for Medical Devices\, solid materials and extracts in both polar and non-polar vehicles.\nIndustry application: Discover how Sonova integrates NAMs into product development for novel materials.\n\nSpeakers \n \nAndy Forreryd\, PhD\nScientific Liaison @ SenzaGen \n\nExpert in in vitro assay development\, genomics\, and machine learning.\nCo-developer of the GARD®skin assay (OECD TG 442E).\nActive member of the ISO/TC 194/WG 8 on irritation and sensitization and OECD expert group on respiratory sensitization.\n\n\n \nKarla Lienau\, PhD\nBiological Safety Specialist and Research Engineer @ Sonova \n\nResearch engineer specializing in new materials\, coatings\, and technologies for custom hearing aids.\nExpertise in biological safety assessments in compliance with ISO 10993.\nWorks with Class IIa Medical Devices\, ensuring safety and regulatory compliance.\n\n  \n \nThe webinar will last around 50 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording.
URL:https://senzagen.com/event/webinar-regulatory-updates-nams-for-medical-devices/
CATEGORIES:Webinar
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