Which of Your Medical Device Testing Problems Can We Solve?

• Marketing wants independent comparative testing
• We need performance testing now for our 510(k)
• We don't have an environmental chamber
• We're not sure what testing FDA expects
• We don't have the specialized test equipment

If any of these look familiar, get help from CITECH, the leading independent test house serving the medical device industry exclusively. We know medical devices and what users and regulators expect of them. Our staff has decades of experience in safety and performance testing of products ranging from luer fittings to patient monitoring systems. We are equipped for electrical, electronic, mechanical, physical, and environmental testing. We can test against national and international standards . . . or we can develop special medical device testing methodology for you.

CITECH tests against ANSI, AAMI, IEC, ISO and EN standards for safety and performance for a broad range of medical devices, ranging from hypodermic needles to complex monitoring systems. This testing can help in the product development process, to support 510(k) submissions, or to justify the CE Mark. Comparative testing by an independent laboratory can also help you demonstrate your device's superiority over its competitors.

We recognize that the test methods in standards aren't always appropriate ... or, there may be no standards for your device. One of CITECH's unique skills is understanding how medical devices are used and developing test methods that reflect this usage.

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