In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will...
Packaging standards continue to develop and evolve a decade after the most recent version of ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices. This presentation will provide an overview of...
Medical devices often go through many changes throughout their normal product lifecycles. Whenever a device goes through one of these changes, it should also undergo a review to determine the...
The regulatory environment for biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have typically been addressed with biocompatibility testing on animals; however, alternate...
