ISO 10993-1 guides the biological evaluation of medical devices. With the Final Draft International Standard (FDIS) approved, this update is one of the most significant in recent years.
The panel covered what is changing and how to prepare. This FAQ material was developed based on the feedback from the discussion. You can view the on-demand webinar “ISO 10993-1 Panel Discussion: Preparing for Updates in the New FDIS” here: view on-demand webinar.
Download the FAQ document here: FAQ ISO-10993-1 FDIS
Have additional questions or need a plan for ISO 10993-1? Nelson Labs Expert Advisory Services helps device and pharmaceutical teams turn requirements into clear, defensible strategies. Our specialists track regulatory trends and serve on standards committees.
For a review of your approach or a roadmap to approval, email:
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