Harshavarthini M Email and Phone Number

Having 3 years and 3 months of experience in complaints handling.Currently,I amdoing Regional Customer Complaints handling project in Trackwise tool.• Intake, investigation and closure of the medical device complaint. The complaints are incorporated from customer via e-mail SMAX and Salesforce tool.• By analyzing the information provided by the customer and the provided reference documents, complaints are created in Trackwise tool.• Complaints are interfaced in the Trackwise if received by salesforce and SMAX tool.• Follow-ups with customers are done when any additional information is needed for intake and investigation of the complaint.• After analysing the complaint thoroughly "Decision tree" is made, which will determine whether the complaint is reportable, or not reportable.• The DT is submitted within 15 days from the complaint awareness date. During investigation, the complaint history record, design history record and risk review of the complaints are analyzed and identified.IMDRF codes are updated according to the identified defect.• CAPA of the defect will be provided by the manufacturer when a similar complaints have occurred.• If the voice of customer and the voice of product met the specifications an MDR is created and sent to FDA.• After the investigation is closed done, the closure process of the complaint will be carried on.• A closure letter will be created and sent for review after the reply from the reviewer closure letter will be sent to the customer