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Wherever you are in your product development lifecycle,
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Medical Device Quality Systems

Need help implementing a Quality Management System?

Are you struggling to develop and implement a Quality Management System (QMS)? Looking for a comprehensive solution that can streamline the process so you can focus on developing and manufacturing high-quality products?

Sterling can help. We specialize in medical devices, IVDs, and digital health and know what it takes to implement a quality system that meets all regulatory requirements without being burdensome for your company. Sterling implements quality systems to be compliant to:

  • ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes)
  • FDA Quality System Regulations (21 CFR Part 820), also known as cGMP (Good Manufacturing Practices)
  • Medical Device Regulation (MDR) 2017/745
  • IEC 62304 (Medical device software — Software life cycle processes)
  • ISO 14971 (Medical devices — Application of risk management to medical devices)
  • IEC 60601-1 (Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance). 
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The quality system we implement for you will follow the regulatory requirements and be compatible with the way you run your business. Let Sterling take the burden of developing your QMS, contact us today.

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.

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August 8, 2022

New Proposed FDA Medical Device Quality System Regulations

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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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Breathing Pacemaker

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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