GMP/QSR/ISO Review

GMP/QSR/ISO Review

All the work we do adheres to stringent guidelines in order to ensure your project is done correctly and timely. These guidelines are Good Manufacturing Practices, Quality System Regulation, and ISO standards.

  • Consulting to help streamline workflows of your Quality System
  • Quality System Review and Gap Analysis
  • Develop and Implement a remediation plan
  • Solving manufacturing system problems in a GMP compliant manner
  • Proven track record of FDA/CE approvals

Sterling Medical Devices has decades of experience helping clients develop devices the right way! We understand that Quality Systems and how they are practiced are very important in the process of Medical Device Development and ultimately in obtaining medical regulatory compliance. That is why all the work we do adheres to stringent guidelines in order to ensure your project is done correctly and in a timely fashion. These guidelines are Good Manufacturing Practices, Quality System Regulation, and ISO standards. These practices and guidelines are followed through many of the stages of the device’s life-cycle and if not could lead to a costly redesign that will also delay your device from reaching the market.

Contact Us

About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Resources

March 29, 2021

What Is Polarion?

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October 22, 2021

What Does it Mean to be ISO 13485 Certified?

Compliance with ISO 13485 and Quality System Regulation (QSR) ensure that your Quality Management System (QMS) is robust and meets the regulatory requirements on the international level. But beyond...
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April 28, 2021

Leading You Into the Next Era of Product Development

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    Dan Sterling Photo of Dan Sterling President
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 dan@sterlingmedicaldevices.com
    John Campbell Photo of John Campbell VP of Operations
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jc@sterlingplm.com
    John Fargo Photo of DanJohn Fargo PLM Manager
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jf@sterlingplm.com