Serving the medical industry for more than thirty years, KMC Systems is an industry-recognized provider of medical product development, design, manufacturing and field support services. Through open communication and collaboration with our customers, and by applying our expertise and proven processes, the KMC Total Product Lifecycle Management Program mitigates development risks, reduces cost and speeds time to market.
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Our customers rely on our extensive experience and proven success record in medical device development. The medical product development stage in the KMC Total Medical Product Lifecycle Program is a key element in the total medical product development life cycle. During the staged medical device development process, our systems engineering team evaluates concept feasibility and architecture requirements with simulation tools in a virtual prototype environment to reduce development risk before investing resources in product design.
KMC systems engineers provide resources that guide our customers through the medical product development process, addressing requirements definition, hardware/software architecture concepts, risk management and hazards analysis, as well as system verification and validation, during the product development stage.
We have developed and refined our medical product development process through our broad experience resulting in a nimble, compliant and efficient approach to medical device product development with results that comply with FDA 21 CFR Part 820, ISO13485, ISO 14971, and ISO 9001.
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