Medical device organizations that manufacture products that involve patient contact are almost always required to perform some level chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.
Join NAMSA for this on-demand webinar, hosted by NAMSA’s biological safety expert, Duane Mancini, to learn about global regulatory requirements for chemical characterization testing and how manufacturers can use chemical characterization to demonstrate biological safety for their devices.
Discussed will be:
- NAMSA’s proprietary testing matrix to determine the most suitable series of tests to create beneficial extractable/leachable programs;
- Examples of when and how to leverage extractables/leachables to address various changes in materials or manufacturing processes; and
- The utilization of extractables/leachables on a new medical device