GMP/QSR/ISO Review

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.