Biocompatibility: Documenting all the Risks
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Join Paolo Pescio, MBA, ERT, Global Director Biocompatibility & Toxicology at Fresenius Medical Care and Geoffrey Moodie, Ph.D. Principal Biocompatibility Engineer, Group Leader at ZOLL for an in-depth discussion on biocompatibility and what the latest regulatory changes mean for you.
Paolo is a technical expert on the ISO committee that developed the new ISO 10993-1:2025 standard and is currently contributing to the development of the forthcoming ISO guidance document on the application of this standard throughout the medical device lifecycle, so you will have opportunity to hear the most current thinking.
Geoff has over 20 years of experience in medical device safety and efficacy testing and is on multiple AAMI committees providing US industry feedback to multiple standards.
Biological risk assessment is not just a checkbox: it’s a critical risk assessment that needs to be treated as such, exploring potential risks from raw materials to manufacturing processes to final packaging and aging, Regulatory agencies are already asking tough questions that go well beyond rote test results. Are you ready to meet this modern expectation?
If you have open questions this is your opportunity to talk to two seasoned experts actively engaged in the field. You’ll gain practical insights into implementing strategies that satisfy regulators while ensuring patient safety. Whether you’re in R&D, regulatory affairs, or quality assurance, this discussion will help you stay ahead of evolving expectations and avoid costly delays or compliance issues.
Register here: https://www.eventbrite.com/e/biocompatibility-documenting-all-the-risks-online-tickets-2000051581119?aff=oddtdtcreator