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Interested in learning more about how we can work together in your current or next medical device design project?

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Wherever you are in your product development lifecycle,
Sterling can help.

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Support for Good Manufacturing Practices, Quality Systems Regulations, and ISO Standards

As you work to get your device to market as quickly and cost-effectively as possible, ensuring it is produced and controlled according to quality standards is essential. Failing to follow the necessary guidelines can lead to costly redesigns, delayed time-to-market, and possibly even a tarnished reputation—all of which will affect your bottom line.

We get it: it’s a lot of dots to connect—and your in-house resources may not have the bandwidth or expertise to address the nuanced details and complexities. That’s where we come in. At Sterling, our team of medical device regulatory experts has decades of experience helping clients design and develop products in accordance with Good Manufacturing Practices (GMP), Quality Systems Regulations (QSR), and ISO standards.  

Whatever your situation—whatever stage in the project lifecycle you’re in—we can help. Maybe you’re just starting the process and you want to be sure your device is designed according to the appropriate quality standards—or maybe you’re much further in and you’re now at the frustrating (and costly) point of redesign. Perhaps your post-market inspection resulted in an FDA form 483 or warning letter. Whatever the circumstance, we’ve got your back. 

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We’ll Help you Adhere to GMP, QSR Requirements and ISO Standards

Our team of medical device regulatory, clinical, and quality assurance experts will help you address any regulatory challenge—or, better yet, minimize those challenges in the first place. We’ll help you:

  • Streamline your quality systems workflows
  • Complete quality system reviews and gap analyses
  • Create and implement a remediation plan
  • Solve manufacturing systems problems in compliance with GMP
  • Quickly and proactively resolve any issue related to a form 483 or the more serious FDA warning letter

Ensuring your device complies with the strict regulations mandated across the medical device industry is not your area of expertise—but it is ours. Turn that burden over to us.

For more information, fill out the contact form.

Additionally, if your company has received an FDA warning letter, fill out our form here and learn more about how Sterling can help you address it.

What does it take to obtain FDA/CE approval?

Regulators want to see a very specific design process, strong quality control, robust risk management and an airtight submission package. At Sterling Medical Devices, the FDA has accepted our thorough Design History Files (DHF) every time, showing that we have tried to think of every possible scenario through software verification and medical device testing. We ensure that the medical device software and medical device hardware are doing what they are supposed to be doing and designed to do.

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