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