At KMC Systems, we solve complex engineering problems for medical OEMs and start-up companies using multidisciplinary expertise, collaborative teams, and proven processes. We have contract designed a broad range of medical devices and instruments ranging from clinical chemistry and immunoassay analyzers to minimally invasive biopsy systems and urine aliquotors.
We have over 70 engineers and program managers on staff. In addition to medical industry expertise, our engineers are well-versed in a number of disciplines, from systems engineering and fluidics to electronic design and software.
At KMC Systems, we apply our 30 years of medical experience and in-depth knowledge of user needs, usage patterns, and technical risk areas to optimally design effective devices. Design for Manufacture and Assembly is embedded in our engineering processes to ensure a seamless, speedy transition to production.
We understand medical industry regulatory standards. Our contract engineering services include stringent quality controls including requirements development, design verification, technical reviews, risk management and analysis. Our proven processes meet the FDA’s Quality Systems regulation and are certified to ISO 13485.
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