Description
This course will review the current regulations and
expectations for the use of risk management processes and
methods in the life cycle of medical devices. We will discuss
the use of the ISO 14971:2000 standard and FDA’s guidance
documents on Human Factors Engineering to provide a clear
understanding of what techniques to use and when they
should be implemented. Practical workshop activities will
provide guidance on how customer use and potential misuse
information can be acquired and used, as well as actual
performance of various risk analysis techniques. The course
will also provide guidance on what type of risk analysis should
be performed at each phase of the medical device history,
from early design concepts through use in the field.
