Most medical device inventions start out as a single great idea, but how does that idea become a
marketed medical device? Here is a brief overview of how a medical device, which can range from a
contact lens to a knee implant to an MRI machine, begins with an idea and ends with its submission
to FDA.
➡️️ Idea, Requirements, Blue print
➡️ Formal development, Concept, Design
➡️️Categories, Risks
➡️️ Clinical Research, Review board, approval procedure
➡️ Trial enrollment, FDA regulated study/research, Doctors, Clinical Investigators, Documentation
➡️ Study close out, completeness check, FDA Inspection
➡️ IDE
The video highlights aspects of the Investigational Device Exemption (or IDE) process, and provides
general information on medical device clinical trials.
The audience is device manufacturers and health care professionals.
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