KMC Systems has been solving complex medical engineering and design challenges since 1980. Leading instrument companies partner with KMC to leverage our proven expertise in conceiving innovative, highly-automated solutions in the development and design of full-system instrumentation. Our engineers work collaboratively with our customers to achieve the best interdisciplinary solution to laboratory automation challenges. We specialize in:
Our medical device product development process starts with establishing a multi-disciplined, dedicated team to work in close collaboration with you on feasibility, Design for Manufacturability and Serviceability (DFM and DFS) challenges, medical device verification and validation. With expert engineers in software, systems, mechanical and electrical engineering―plus seasoned program managers, quality control and manufacturing professionals―you can rely on KMC to ramp up quickly and deliver on every detail of your desired platform.
Collaboration is ongoing, transparent, iterative, and agile.
Our engineers are not only experts in their own fields; they know how to work across knowledge domains to achieve the best interdisciplinary solution to an automation challenge. Plus, they speak the language of the scientist and can communicate with your specialists at their level.
Our medical device design services include stringent design controls, technical design reviews, design verification, risk management and analysis. Each of these is completed with you in the loop. Our proven processes comply with the FDA’s Quality Systems Regulation 21 CFR Parts 820, 803 and 806, as well as ISO 13485: 2003 and IEC 62304.
KMC Systems offers a centralized workforce of experts in engineering, manufacturing, quality control and supply chain management to provide innovative biomedical instrumentation. Download the KMC Brochure to learn more about our full-system design, development,manufacturing and service capabilities.