Medical Device Quality Agreement for US

SKU: QA-US
$149.00
$149.00
Unavailable
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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Medical Device Quality Agreement for US

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
​The Quality Agreement includes detailed table of responsibilities to clearly define both parties responsibilities to ensure a proper "meeting of the minds" and clarity as to each parties role for each defined topic.

Medical Device Quality Agreement Compliance

The Medical Device Quality Agreement for US complies with FDA Requirements for Supplier Management including FDA QSR.
For more information regarding our Medical Device Quality Agreement contact us at info@aplyon.com
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Medical Device Quality Agreement
Medical Device Quality Agreement
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