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Virtual Investigational Device Exemption (IDE)

Apr 29, 2011 8:00am ‐ Apr 29, 2011 5:00pm

Credits: None available.


While didactic presentations can give you the tools, most practical skills are best ""learned-by-doing"". The Center for Devices and Radiological Health (CDRH) Virtual IDE (Investigational Device Exemption) exercise will challenge you to make strategic analysis decisions in a sequence, which simulates the development of a medical device and keeps you in FDA regulatory compliance. Attendees will develop strategies for handling these compliance issues and will also factor in time and resource demands. Each possible strategy possesses its own set of consequences that the group must address. At the culmination of the workshop, each group will describe their analysis and strategies for the challenges they faced during the exercise. This workshop provides solid techniques to make the training more engaging such as a practical, hands-on learning experience with frequent interaction from members of their group and the instructors.

  • Discuss the medical device developmental process and the balance between superior development and rapid delivery to market.
  • Recognize investigational research activities that may derail medical device development.
  • Identify risk management techniques that keep your device research in compliance.



Credits: None available.

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