Supplier Terms

As a supplier to a medical device company, the following terms and conditions apply.

Manufacturing Practices

If Buyer advises Supplier that the goods (if any) to be delivered under the purchase order will be used in the finished product that is regulated by the United States Food and Drug Administration and/or any other applicable government or regulatory authority, then supplier will follow all current good manufacturing practices stipulated or promulgated by such governmental or regulatory authority, as the same may be changed from time to time, that are applicable to the manufacture, packaging, labeling, handling, shipping or storage of such goods.

Quality System

Supplier agrees to maintain a Quality System that meets or exceeds industry and/or regulatory standards, preferably 21 CFR Part 820 or ISO 13485 as appropriate for medical devices.  Supplier also agrees to ensure product conformance to specified requirements and to maintain adequate quality records and objective evidence to demonstrate such conformance.

Suppliers and vendors or products and services to ROi CPS, LLC must notify ROi CPS in writing of any changes in the product or service prior to delivery.

If applicable, vendor agrees to comply with the provisions of the Equal Opportunity Clause, incorporated in this purchase order by reference, as set forth in paragraph 60-1.4 of the regulations of the Secretary of Labor (41 CFR Chapter 60), issued pursuant to Executive Order 11246 of September 24, 1965.  Vendor is aware and fully informed of its responsibilities under the Rehabilitation Act of 1973 Section 503 (41 CFR 60-741) and Executive Order 11758 dated January 15, 1974 (41 CFR 60-250) and hereby agrees that it shall comply with the requirements of said orders.