COMPLAINTS / FAILURE ANALYSIS Sample Clauses

COMPLAINTS / FAILURE ANALYSIS. Lake Region will be the responsible legal manufacturer in the United States and will file all reports required by FDA’s Medical Device Reporting (“MDR”). Lake Region will have primary responsibility for managing all US originating complaints using the Lake Region Medical complaint management process. Silk Road Medical will be the responsible legal Manufacturer in the European Union and will file all reports required by Medical Device Directive’s Vigilance Reporting regulations. Silk Road Medical shall contract with an European Authorized Representative as listed on the Product labeling. Silk Road Medical will have primary responsibility for managing all EU originating complaints using the Silk Road Medical complaint management process. The regulatory process owner for all other regions of the world shall be mutually agreed in writing and shall be responsible for medical device reporting and complaint management for other worldwide regions. Silk Road Medical will maintain and manage a file of all complaints received by Silk Road Medical with respect to the Products. Upon Silk Road Medical’s receipt of any Silk Road Medical complaint alleging that any Product is defective, Silk Road Medical will promptly send to Lake Region’s complaint analysis department a copy of such complaint. If the allegedly defective Product is returned to Silk Road Medical by its customer, Silk Road Medical will perform an initial internal failure analysis and, if a preliminary determination is made that the defect is possibly related to the device, may thereafter notify and forward the allegedly defective Product to Lake Region’s complaint analysis department and require Lake Region to perform an independent failure analysis of the returned Product(s). Lake Region and Silk Road Medical will cooperate with each other in investigating complaints, sharing information and submitting any report required including providing duplicate copies of all such failure analysis reports along with full and complete information on the failure. If Silk Road Medical provides either allegedly defective Products or samples of Products suspected to have problems or defects, Lake Region shall, upon written request, return such Products to Silk Road Medical after Lake Region has performed the necessary analysis. Lake Region may, at its option and at its expense reinspect any unused Product believed to be defective or non-compliant at Silk Road Medical’s premises or perform the reinspection at its own facil...
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