Medical Device Quality Agreement | United States
Define quality and regulatory responsibilities between a medical device company and its supplier for products intended for distribution in the United States. This editable Word agreement addresses approvals, labeling, quality system duties, complaint handling, corrections and removals, FDA registration and listing, and amendments.
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Supplied as one editable Microsoft Word document in a digital download.
Quality responsibilities and agreement scope
The Medical Device Quality Agreement for US defines the responsibilities of the "Supplier" and "Company" for the following subject matter:
Regulatory Clearances and Approvals
Medical Device Labeling
Quality System Requirements (each QMS element)
Complaint Handling and Reporting
Corrections and Removals
FDA Registration and Listing
Amendments to Agreement
Use this agreement to document how the parties allocate supplier-related quality responsibilities. Tailor the terms to the actual products, roles and activities before signature.
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Quality Agreements and Consulting Contracts for workflow guidance, a checklist and common mistakes.
Related documents
The Supplier Management Procedure supports the separate workflow for selecting and monitoring suppliers. For a manufacturer–distributor relationship in Europe, see the separately sold European Medical Device Quality Agreement.
