Systems Engineering
Requirements Definition
The requirements definition is the foundation of a medical device design project. KMC Systems’ experience at synthesizing diverse marketing, technical, regulatory, quality, and service information results in verifiable requirements that are focused on system performance, cost-effectiveness, and end-user satisfaction. We closely coordinate the development of the Systems Requirements with the Software Requirements and Risk Management activities to provide the most efficient balance of mechanical, electrical, and software functionality.
System level requirements are decomposed further into module level requirements and design documents. These documents ensure all details necessary to meeting the requirements are documented, including architecture, operating principles, and design rationale.
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