The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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...
