Medical Instrumentation Engineering and Design
At KMC Systems, we solve complex medical device development and design challenges for leading and emerging medical device companies. Conceptual development and design has been a KMC Systems strength for over three decades. Our engineers are industry-recognized for instrument platform development and are 7adept at solving complex challenges in laboratory automation markets.
With expert engineers in multiple disciplines -- software, systems, mechanical and electrical -- plus seasoned program managers, quality control and manufacturing professionals, KMC 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.
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.
- 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.
Through open collaboration with our customers, KMC’s design team focuses on meeting your unique product requirements. From product conceptualization and feasibility through prototype development and system verification, KMC applies it’s comprehensive, cross- functional engineering expertise to solve complex problems.
When success is paramount, take it to KMC.
To see how KMC Systems turns smart ideas into brilliant reality, download our Total Product Lifecycle Chart.