Generic filters
Exact matches only
Generic filters
Exact matches only
Header Artwork
Header Artwork

Author: Nicholas Christiano





September 23, 2025

ISO 10993-1 FDIS Updates: What the Risk-Based Approach, Particulates, and Contact Time Changes Mean for Medical Device Teams

The Final Draft International Standard (FDIS) of ISO 10993-1 introduces the most significant updates in decades to the biological evaluation of medical devices. Among other things, these revisions reinforce a risk-based framework aligned with ISO 14971, expand expectations for particulate...

See Blog

September 3, 2025

ISO 10993-1 FDIS Updates: FAQ from the Panel Q&A

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...

See Blog
Footer Artwork