Medical Device Quality Agreement | United States
The Medical Device Quality Agreement for US defines the individual responsibilities of the parties as to the regulatory and quality aspects of a medical device intended for distribution in the United States. The Quality Agreement is intended to be used to define the division of responsibilities between the parties and to demonstrate their compliance with applicable regulatory requirements of the United States Food and Drug Administration (FDA).
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The Medical Device Quality Agreement for US defines the individual responsibilities of the parties as to the regulatory and quality aspects of a medical device intended for distribution in the United States.
Medical Device Quality Agreement Overview
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
Medical Device Quality Agreement Compliance
The Medical Device Quality Agreement for US supports implementation of FDA Requirements for Supplier Management including FDA QMSR.
For more information regarding our Medical Device Quality Agreement contact us at [email protected]
Regulatory framework
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.
