IQ/OQ/PQ

IQ/OQ/PQ

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are three qualifications used to ensure the effectiveness and safety of the machinery and tools utilized throughout the medical device development process. Sterling takes these medical device qualifications into account when helping medical devices during their development and design processes, ensuring that our client’s medical devices have a qualification process that runs smoothly and quickly.

  • Keeping comprehensive and orderly design history files
  • Ensuring that your device’s prerequisite conditions for expected functionality are in order
  • Continually testing devices throughout the development process
  • Creating test plans for functionality
  • Ensuring that system and unit testing occurs

Sterling has helped hundreds of devices go through the proper medical device qualifications to ensure they meet the regulatory requirements for GMP. Sterling’s expertise can help any client receive all three of these medical device qualifications for their medical device.

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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

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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Potential Coronavirus Treatment

April 29, 2020

Sterling Medical Devices Partners with Cedars-Sinai and Aytu BioScience on Potential Coronavirus Treatment

MOONACHIE, NJ, April 29, 2020 — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, announced today their partnership with...
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