With the most recent release of ISO 10993-18 (January 2020), further developed is the concept of Biological Evaluation of Medical Devices within a Risk Management Process. This critical information has been long waited for by global medical device manufacturers provided the original release of ISO 10993-1 was in 2005 (with an updated version in 2018). Now, with the new standard available, it is critical that professionals involved with the biological evaluation of medical devices understand the standard’s use, interpretation, requirements and how an effective link now exists to the overall biocompatibility evaluation as described in ISO 10993-1.
This LIVE webinar, presented by Don Pohl (Principal Product Development Strategist—NAMSA), will take look at ISO 10993-18:2020 and highlight the key aspects which have been incorporated into the standard and how these may impact strategies developed for the safety evaluation of a device. Some key questions to be discussed and presented include:
- What are the most significant changes to the standard?
- How has the chemical characterization process changed with the release of this standard?
- How can I use chemical characterization in the biological evaluation of my device?
- What do I need to start doing differently today because of this update?