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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

quality systems regulations

November 17, 2021

Understand Quality Systems Regulations to Avoid FDA Enforcement Actions

Medical devices are regulated in the United States by the Food and Drug Administration (FDA) because of the great responsibility and risk they carry regarding human life. To be sold in the U.S., 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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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