ISO 10993-1 Panel Discussion: Preparing for Updates in the New FDIS
Автор: Nelson Labs
Загружено: 2025-07-29
Просмотров: 557
ISO 10993-1 is a foundational standard for the biological evaluation of medical devices, guiding how manufacturers assess safety and meet global regulatory requirements. With the Final Draft International Standard (FDIS) now approved, we’re looking at one of the most significant updates to biocompatibility standards in recent years.
As many people are eager to understand these latest changes, three of our biocompatibility experts will hold a live panel discussion about the key changes to ISO 10993-1. These experts will cover the following updates to the standard:
• Enhanced risk-based approach
• Clarified guidance and expansion on device classification
• Increased genotoxicity application
• Improved integration with ISO 14971
• Updated guidance on biocompatibility at end of life and for reusable devices
• Updated or expanded guidance annexes and test methods
The presenters will open the discussion up for a Q&A session. Take advantage of this opportunity to gain practical insights from our biocompatibility experts into how these changes may impact your product development and regulatory submissions.
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