The Center for Professional Advancement, Amsterdam, The Netherlands
12-13 July 2007
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 US, 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 14971:2000 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.
Course Type: A Two-Day Intensive Course
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