Nizam Mohammed

Clinical Specialist @Mortara Instrument

Milwaukee, WI, US

Review potentially reportable complaints that have been escalated by the Complaint Handling Unit (CHU) and determine if an adverse event should be reported to regulatory agencies.• Assisting the Complaint Handling Unit (CHU) with writing regulatory rationales for complaint closure.• Providing clinical input for Engineering during pre-market risk assessment.• Identifying patient and/or user risks related to environmental and/or medical device use/workflows; assists with identification of existing or potential mitigations.• Providing clinical input for Design Quality Assurance during post-market risk assessments.• Submitting electronic MDR’s for malfunctions and serious adverse events using the FDA electronic submitter/Webtrader.• Providing clinical training for company personnel on products, clinical markets and use environments.• Review and approve quality system documents that require clinical input.

Rush University

Master of Science (MS)

NTR University of Health Sciences

Doctor of Medicine (MD)