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...
One of the core tenets of ISO 10993-1 is the risk-based approach for determining the safety of a medical device. In the new revision of the standard there is an emphasis on the qualifications of the people performing the evaluations...
Sample representativeness and quantity determination for test articles have been discussed in my previous posts. Continuing on the topic of what to consider when performing biological testing, this post will cover the extraction conditions to be applied for testing. Extraction...
At this year’s MD&M West trade show, Nicholas Christiano, Global Segment Leader for Biological Safety at Nelson Laboratories, presented on updates to the new revision of ISO 10993-1, the cornerstone standard guiding biocompatibility assessments for medical devices. ...
