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.