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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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Product Development

KMC Systems is an industry recognized provider of medical device and instrumentation design, manufacturing, and field support services; serving the medical industry for more than 30 years.

Our extensive experience and demonstrated track record are the foundation of our branded KMC360® services.

The KMC360® design, manufacturing, and field support services are offered as key elements of the proven processes for medical device total product development life cycle management. Our staged medical product development process has been demonstrated to comply with FDA 21 CFR Part 820, ISO13485, ISO 14971, and ISO 9001. KMC has developed and refined this process through our broad experience resulting in a flexible, compliant, and efficient approach to medical device product development and project management.

The Systems Engineering team provides the resources to 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.