QARA Consultant

• 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) All your information will be kept confidential according to EEO guidelines. Deegit Inc.