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Deegit Inc.
· Review and approval of the clinical workflow definitions for the subject devices
· Identification of the clinical hazards and associated harms for the subject devices
· Estimation of the severity and probability of occurrence for the clinically related hazardous situation
· Development of the clinical benefit statements for the subject device
· Understanding of device development in an FDA regulated environment
· Experience with ISO 14971 risk management activities
· Experience with the post market medical device support (complaint or risk analysis)
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