Quality Assurance

Quality Systems

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.

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QMS Compliance & Remediation

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.

Other Services

QMS Design, Implementation, and Training

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.

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Quality Management Systems Auditing

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.

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Resources

Medical Device Cybersecurity

December 20, 2021

Why Medical Device Cybersecurity Matters

In our post-pandemic, socially distant world, tech-enabled distributed healthcare has become ubiquitous. As medical devices get more advanced to support this evolving landscape, so do the...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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