Systems Engineering
System Verification
For medical devices and instrumentation, verification and validation are required to bring products to market. At KMC Systems, we understand the verification and validation requirements faced by our customers. Our proven process provides verification traceability from design input to product output. Our design control and efficient manufacturing processes then provide product suited for validation.
While verification takes place toward the end of the product design cycle, our preparation efforts begin on day one with the development of detailed requirements specifications. We implement rigorous design controls to ensure that product designs meet the requirements, and conduct and document technical reviews throughout the entire engineering process so each and every defined requirement is satisfied.
Reliability verification is not required by the FDA; however, it is important that our customers’ products perform consistently and meet service plans. KMC Systems can provide verification of system and/or module reliability via analysis or testing. KMC Systems’ expertise in electronics and software architectures often enables module reliability testing to begin early in the development cycle to provide more efficient design feedback before reaching the verification phase.
Once products have been fabricated and integrated according to approved drawings, component specifications, manufacturing procedures, and acceptance test procedures, our customers validate the product through user testing. The purpose of validation is to confirm that the designed medical instrument satisfies its intended use in the use environment.
For validation, we assist customers through provision of comprehensive design history files, including technical data required for regulatory approval from drawings of critical parts to source code listings. We and can also provide consultation when requested.
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