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Small Walt Question: My company is developing a  complex disposable cartridge for a  point-of-care technology, but will hire a  contract partner to design and  manufacture the instrument itself. At what point should we engage the partner and begin the design phase? Answer
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Medical Device Design

Design

At KMC Systems, we solve complex medical device engineering problems for medical OEMs and start-up companies. This is done using our multidisciplinary expertise, collaborative teams, KMC’s off-the-shelf technology, and proven processes.

With more than 80 engineers and program managers on staff, we can handle your greatest 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 industry regulatory standards. Our contract engineering services include stringent quality controls across the Total Product Life Cycle, 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 and instrumentation customers have different contract engineering needs. Whether you require support from concept design through manufacturing or just for product design modifications, we can support your needs.

Our design projects are typically in five 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.