QMS Compliance & Remediation

Sterling has decades of experience helping clients achieve and maintain regulatory compliance.

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. In a highly regulated industry, managing the everyday manufacturing process can be challenging enough. Tack on added nonconformance in quality management, and you’ve got a constellation of headaches and complexities that may prove too much for your in-house resources to handle. But the cost of nonconformance is too high for you to ignore. 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.

FDA Form 483 Inspectional Observations and Warning Letters Support:

A Form 483, also known as “Inspectional Observations,” may be issued at the conclusion of your quality conformance inspection with a nonconformance report that cites certain conditions that may violate the Federal Food, Drug, and Cosmetic (FD&C) Act. A warning letter is considered an escalation of the Form 483. Whether you’re dealing with a Form 483 or the more serious FDA warning letter, we’ll help you respond to the notice within the required timeframe and address the violations in question.

With our QMS compliance and remediation knowledge, we’ll help you figure out how to answer a nonconformance report by specifically helping you:

  • Analyze the findings of the FDA Form 483 and/or warning letter to understand what the nonconformance is
  • Develop a nonconformance management procedure to address the deficiencies
  • Create a timeline for implementation
  • Lead or assist in the implementation of the plan to address the deficiencies
  • Act as an interim management representative
  • Field questions from you or the FDA during corrective action activities

Don’t learn the consequences of nonconformance the hard way. For more information about our QMS compliance and remediation services or how we can help you develop a nonconformance standard operating procedure to ensure QMS compliance with regulatory bodies, contact us here.

Sterling’s independence gives you the flexibility to work with a medical device quality system that is optimized for your needs. Whether it’s creating a medical device quality system from scratch with our team, remediation and reconstruction of an existing one, or relying on one of our own formulated quality systems, quality is Sterling’s priority.

Resources

September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...
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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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November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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