Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan.
In today’s world, however, the simplicity of the above process is increasingly questioned given the requirements of ISO 10993-1: Biological evaluation of medical devices; Part 1 – Evaluation and testing within a risk management process. This is in part due to the requirement set forth within ISO 10993-1 that indicates medical device manufacturers go beyond the minimalistic process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety.
This webinar, presented by Don Pohl (Principal Product Development Specialist, NAMSA), will take a look at the basic requirements of ISO 10993-1 and how device organizations can effectively identify processes to meet regulatory standard for multiple regulatory bodies.
Questions to be addressed include:
- What tools are available to device manufacturers to help identify an appropriate testing strategy?
- When are specific tests necessary and unnecessary, and what determines this?
- Does a “check box” approach still guarantee regulatory approval?
- Outlook on ISO10993-1 potential changes and timing