Since 1997, the FDA has taken strides to revolutionize the implementation of quality systems by creating the Quality System Regulation standards—standards that Sterling has followed since our founding. Our FDA compliant processes provide clients guidance through complexity to achieve a successful medical device that sets the bar for high quality in the industry.
As a medical device manufacturer, you are likely all too aware of the looming threat of nonconformance findings, an FDA 483 response, or the dreaded FDA form 483 and warning letter. At Sterling, we’ll remove this burden so that you can confidently and expediently respond to the regulatory body’s call for action with our QMS compliance and remediation services.
With advanced expertise in quality management system implementation, medical device quality assurance, and regulatory compliance, we will partner with you to build a robust QMS that ensures product quality and patient safety while meeting the regulatory requirements on an international level.
Our team of medical device regulatory, clinical, and quality assurance experts are available to supplement your organization’s efforts, address an immediate regulatory challenge, or assist during periods of organizational transition. We’ll help you check all the boxes to ensure your QMS meets all applicable regulatory requirements.
December 20, 2021
February 18, 2021
September 8, 2020
