Risk Management Today: Complying with the ISO 14971: 2007 Standard
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Who Should Attend
This course is designed for those who work in the medical
device industry and who currently are or wish to design and
sell their products in U.S., Europe and other parts of the
world. This includes, but is not limited to those in the following
functions:
• R&D and Quality Engineering
• QA or Regulatory
• Engineering and Manufacturing
All participants will gain tools to incorporate risk analysis
throughout the quality system in compliance with global
regulations and to ensure safe devices.
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 14971:2007 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.
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