EX-10.50
from DRS/A
6 pages
This Quality Agreement (“Agreement”) Between Syncardia Systems, LLC, With Principal Offices at 1992 E. Silverlake Road, Tucson Az, 85713-3865 and Greatbatch Ltd., Syncardia Level 2 (Crucial) Supplier (“Supplier”), With Principal Offices at 10000 Wehrle Drive, Clarence, Ny 14031, Describes the Commitment Both Parties Agree to Make to Ensure That Their Respective Products and Services (“Product”) Satisfy the Quality Requirements Called Out in This Agreement. 1. Definitions A. Design History File (Dhf): A Compilation of Documentation That Describes the Design History of a Product. B. Device Master Record (Dmr): A Compilation of Records Containing the Procedures and Specifications for a Finished Device. Supplier-Generated Dhf Records May Be Requested as Part of the Dmr. C. Industry Standards: As a Medical Device Company, Syncardia Requires Suppliers to Reference the Following Standards as Applicable to Syncardia Product: I. 21 Cfr Part 820 Quality System Regulation II. Ghtf/Sg3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained From Suppliers III. Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements, May 2013 IV. Iso 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
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