Lake Region definition
Examples of Lake Region in a sentence
Each shipment of Products to Silk Road Medical will be accompanied by a Certificate of Conformance to ensure that Lake Region has complied with the specifications.
Lake Region will have primary responsibility for managing all US originating complaints using the Lake Region Medical complaint management process.
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”).
If there are any differences or inconsistencies between the terms of the purchase order and the terms of this Agreement, or additional duties on, or liabilities to Lake Region, the terms of this Agreement shall govern and any such duties or liabilities shall be inapplicable.
Silk Road Medical will return and Lake Region will promptly replace the Products, which, upon reinspection by Lake Region, fail to meet Specifications.
Lake Region warrants that it will manufacture the Product in accordance with current Quality System Regulations (“QSR”) for medical devices as mandated by the FDA and in compliance with International Standard ISO 13485 and with any and all other applicable federal, state and local laws, rules, and regulations.
Lake Region will maintain traceability to the raw material lots used in the fabrication of the Product for a minimum period of 25 years.
If the employee is transferred to a different work site which is outside the same geographical region for which the transportation allowance was to apply (e.g. the Fort ▇▇▇▇▇▇▇▇ region, the Cold Lake Region, etc.), that employee will be paid any outstanding transportation allowance(s) with their next regular pay.
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 facilities.
Lake Region Medical is responsible for Product user information and labeling format, with assistance from Silk Road Medical regarding branding and format.