We are very proud that our CTO, Carsten Senholt, has a central role in the international writing group developing ISO 10993-17, which was recently submitted as a final draft.
The ISO 10993 series is a suite of standards covering the biological evaluation of medical devices. The newly revised part 17 now covers the toxicological risk assessment of medical device constituents.
This work started over seven years ago and, compared to the 2002 edition, is a fundamental update on how to conduct toxicological risk assessments of medical devices.
We have already implemented this new approach into our processes via our ISO 13485-certified quality management system.
We can help you keep up with the changing world of medical device guidelines.