June 27, 2019 @ 11:00 am
For reusable medical devices, ensuring patient safety is a shared responsibility. The ability to render devices safe for re-use is subject to the demands of device design and function, clinical application, and reprocessing execution.
September 5, 2019 @ 11:00 am
With the ever increasing requirements in medical device regulations about risk management, considering all potential options in your biological evaluation plan (see ISO 10993-1: 2018) can help identify potential hazards in biocompatibility testing as well as determining a path forward when positive results are observed.