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X-WR-CALDESC:Events for SenzaGen
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DTSTART;TZID=Europe/Stockholm:20261028T160000
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SUMMARY:Webinar: Advancing Medical Device Biocompatibility testing with NAMs
DESCRIPTION:Regulatory updates\, industry case studies\, and newly published evidence for wearable devices\nCan the “Big Three” be addressed using non-animal methods? Scientifically validated in vitro approaches are available to assess cytotoxicity\, skin irritation and skin sensitization\, supporting more predictive and human-relevant biocompatibility testing. As the regulatory landscape continues to evolve\, medical device manufacturers face growing opportunities to incorporate these methods into biocompatibility assessments and regulatory submissions. \nJoin us for a webinar exploring the latest developments within the ISO 10993 framework and how New Approach Methodologies (NAMs) are being applied in practice. We are also pleased to welcome Florian Gerdts\, Team Lead Process Development at Element 22\, who will present a case study on metallic 3D-printing materials. \nThrough regulatory perspectives and industry case studies\, our speakers will discuss how in vitro methods can support decision-making from early material screening to CE-marking submissions. \nJust published: We will also present findings from a newly published peer-reviewed study on wearable devices\, providing new evidence for the use of GARD® assays in assessing both constituents and finished-product leachables. \nBuild readiness\n• Develop your NAM database\n• Gain testing experience\n• Strengthen weight-of-evidence assessments \n \nThe webinar will last around 45 minutes\, followed by a live Q&A. If you cannot attend the live event\, register anyway to receive the recording. \nKey takeaways\n\nRegulatory insights: Stay informed on the latest developments in ISO 10993-5\, ISO 10993-23 and ISO 10993-10\, and the growing role of in vitro methods. \nGARD® advancements: Learn how GARD® supports both skin sensitization hazard and quantitative potency assessment of extractable medical devices and solid materials in polar and non-polar vehicles. \nIndustry application: Discover how NAMs are used as weight-of-evidence in CE-marking submissions\, testing of 3D-printed oral devices\, metallic 3D-printing materials\, and early-stage material screening.\nFeatured publication: “Assessing the skin sensitizing potential of constituents and leachables from wearable devices using GARD®” by Persaud et al. (Apple\, SenzaGen). Learn how the study applies GARD® assays to both wearable device constituents and finished-product leachables.\n\n\nSpeaker\n \nAndy Forreryd\, PhD\nScientific Liaison Manager @ SenzaGen \n\nCo-developer of the GARD®skin assay (OECD TG 442E).\nMember of the ISO/TC 194/WG 8 on irritation and sensitization.\nMember of OECD expert group on respiratory sensitization.\n\n  \n \nFlorian Gerdts\nTeam Lead Process Development @ Element 22 GmbH \n\nMaster of Materials Science and Engineering\, CAU Kiel\nTitanium Powder Metallurgy Expert\n> 14 years of experience in Titanium Pulver Metallurgy.\n\n  \n \n  \n\n 
URL:https://senzagen.com/event/webinar-medical-device-biocompatibility-testing-2026/
CATEGORIES:Webinar
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