QMS Design, Implementation, & Training

Production without a stringent Quality Management System (QMS) may adversely affect the reputation of a company, whether that means decreased consumer confidence, compliance issues, corrective actions by regulatory bodies, or insolvency. A QMS refers to a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives related to design, manufacturing, supplier management, risk management, and much more. As a medical device manufacturer, you’re responsible for QMS implementation and maintenance that address the complex product development lifecycle while ensuring compliance with relevant regulations and standards, including ISO 13485, QSR, MDSAP, and more, depending on where your device is sold. For many, the process of how to set up a quality management system can prove daunting and overwhelming. Sterling’s quality management system consultants can help.

With advanced expertise in quality management system implementation, medical device quality assurance, and regulatory compliance, we will partner with you to build a robust QMS that ensures product quality and patient safety while meeting the regulatory requirements on an international level.

Sterling has decades of experience helping clients develop devices the right way. 

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QMS Guidance to Achieve Compliance

Our QMS consultants will help you understand what a quality management system is for your organization. We will also help you with QMS design and implementation that’s easy to use and FDA-, ISO- and MDSAP-compliant, depending on your markets of interest. Following QMS implementation, we’ll offer your team QMS training courses to learn how to use it and help them understand their quality management system roles and responsibilities. We’ll do regular check-ins to ensure your system is compliant with relevant standards and guidance as they emerge. If you have an existing QMS in place, no problem; we can integrate with your system as well. We can give you a template that shows what your QMS should have, show you how to use it, and partner with you to implement it. We’ll also work with you to create and integrate a CAPA (Corrective and Preventive Action) system into your QMS design to ensure your processes include QMS design control and a systematic way to investigate, analyze, and resolve identified issues.

At Sterling, we understand that quality systems—how they are developed, practiced, and maintained—are paramount to successful medical device development and compliance. Whichever system you use—yours or ours—we’ll help you ensure adherence to the relevant guidelines to support a well-designed medical device, a smooth regulatory approval process, and faster time-to-market.

More specifically, we can help you:

  • Design and implement a QMS system from scratch
  • Conduct a gap analysis of your current QMS for relevant standards and guidances
  • Expand the scope of your QMS
  • Build a QMS template that dictates required components
  • Develop a QMS implementation project plan
  • Conduct QMS training for employees
  • Ensure ongoing compliance with FDA, ISO, MDSAP, and more
    • ISO 13485:2016 QMS Creation and Implementation (FDA/EU)
    • MDSAP QMS Implementation
    • FDA QSR QMS Implementation
    • EU MDR and IVDR QMS Creation and Implementation

At Sterling, we understand that QMS design, implementation and training are paramount in medical device development and regulatory compliance. That’s why all the work we do adheres to stringent guidelines to ensure your project is done correctly and timely. To learn more about how Sterling can help you build and maintain a comprehensive QMS for your medical device, contact us here.

Sterling’s independence gives you the flexibility to work with a medical device quality system that is optimized for your needs. Whether it’s creating a medical device quality system from scratch with our team, remediation and reconstruction of an existing one, or relying on one of our own formulated quality systems, quality is Sterling’s priority. 

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

August 26, 2021

FDA’s Software Precertification Program

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a...
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February 18, 2021

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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November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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