Medical Device Quality Agreement Template

Medical Device Quality Agreement Template Prepared by Dan O'Leary Ombu Enterprises, LLC. 3 Forest Ave. Swanzey, NH 03446. 603-209-0600. This document is intended to form the basis for a Supplier Agreement for a Medical Device manufacturer. The document should be tailored to the specific requirements based on the product or service procured, the capability of the customer, the capability of the supplier, and the regulatory framework applied to the Medical Device . Contents 1 Administrative 4. 4. Parties to the 4. Definitions, Abbreviations, and Acronyms .. 4. Referenced Documents .. 5. Products and Services Covered By This Agreement .. 6. Site(s) 6. Quality management Systems .. 7. Quality System Regulation .. 7. ISO 13485:2003 .. 7. ISO 9001:2008 .. 7. ISO 14971:2007 .. 7. Other Required Standards .. 8. Use of Third Parties .. 8. Directed Procurement .. 8. Supplier Selected .. 8. Term of 9. Assignment .. 9. 2 Compliance .. 9. 9. Specification 9. Activity by Regulators, Notified Bodies, or Certification Bodies.

Medical Device Quality Agreement Template Page 6 of 17 Prepared by Ombu Enterprises, LLC www.OmbuEnterprises.com ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes

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  Devices, Management, Medical, Quality, Agreement, Template, Quality management, Medical device quality agreement template

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