CITECH tests against ANSI, AAMI, ASTM, IEC, and EN standards for safety and performance of a broad range of medical devices. We also develop test methodology to fit your needs.

Comparative testing against predicates can support your
510(k) claims of substantial equivalence.

Learn more about our medical device testing services

CITECH is accredited by the U.S. Food and Drug Administration (FDA) as a third-party reviewer for all eligible 510(k) submissions.

This alternative to direct FDA submission can help get your product on the market months sooner.

Learn more about our 510(k) review services