Risk Analysis and Human Factors Engineering
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Who Should Attend
Participants who work in the medical device industry and
who currently are or wish to design and sell their products
in US, Europe and other parts of the world will profit by
attending this course. R&D and Quality Engineers who
participate in designing medical devices will find practical
guidance and techniques they can use to comply with
these current requirements to enhance safety of devices
and increase speed to market. QA or Regulatory
functions who are responsible for understanding and
interpreting global regulations within their companies also
need to understand this topic. Engineering and
manufacturing functions will profit by knowing how to use
the techniques to meet process requirements and
increase efficiencies. All participants will gain tools to help
understand customer use issues and to better prepare devices to ensure safe use.
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.