Since 1988, CITECH has provided medical device testing and consulting services to the medical device industry exclusively. Our services include safety and performance testing of medical devices, as well as third-party 510(k) review.
Our specialization in medical devices and a world-class medical device testing facility combine to make CITECH unique among testing laboratories. CITECH test reports are recognized by FDA and by regulatory agencies worldwide. Comparative testing of medical devices by CITECH can provide a marketing edge.
CITECH's staff understands medical devices. We know what users expect of products and what regulators expect from manufacturers. CITECH understands safety . . . performance . . . human factors . . . and the relevant standards and regulatory requirements. We can develop practical test methods where no standards apply.
As an FDA-accredited third-party reviewer of all eligible 510(k)s, CITECH can help clients get their product into the U.S. market months sooner than through the traditional FDA review.
CITECH is an independent organization that shares a 120,000 square-foot suburban-Philadelphia facility with ECRI, the world's largest independent evaluator of healthcare technology. The facility includes a laboratory dedicated to electronic, mechanical, and environmental testing of medical devices.
About CITECH
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