KMC Systems Medical Device Design
At KMC Systems, we solve complex medical device design and engineering problems for leading medical device companies, OEMs and start-ups. This is achieved by applying our multidisciplinary expertise, collaborative teamwork, KMC’s innovative off-the-shelf solutions and our proven processes.
With more than eighty software, mechanical and electrical engineers and program managers on staff, we can handle your greatest medical instrumentation design challenges. Our industry-recognized medical device design experience is sustained by our talented mechanical engineering, electrical engineering, software engineering and systems engineering team.
We understand medical instrumentation design and the industry regulatory and quality standards. Our contract engineering services include stringent quality controls across the Total Product Lifecycle, including requirements definition and development, technical design reviews, design verification, risk management, and analysis. Our proven processes comply with the FDA’s Quality Systems Regulation 21 CFR Parts 820, 803 and 806, as well as ISO 13485:2003.
Our medical device design customers have different contract engineering needs. Whether you are a medical device company that requires support from concept and design through manufacturing and commercialization, design modification, or you have a design and need to transition to manufacturing, our experienced team of experts will support your needs.
Is your product ready to transition from design to manufacturing? Download our Manufacturing Readiness Review Checklist to find out.
Our design projects typically fall into the following areas of expertise:
- Full-System Development – engineering services from initial concept design through release to commercialization.
- Major Subsystem Development – develop and build major instrument subassemblies.
- Instrument Enhancements – develop engineering solutions for customer-defined issues with existing products.
- Feasibility Studies and Design Reviews – work as consultants, guiding our customers as they develop medical devices and instrumentation.
- Transition to Manufacturing – apply our engineering and manufacturing expertise to ensure designs are manufacturable and for an efficient and rapid transfer to manufacturing.