Carnelian Medical specializes in small, wire-based medical device assemblies.  We have over 60 years of experience designing and developing medical devices such as guidewires, snares, and other minimally invasive devices. We take a hands-on approach to design and contract manufacturing and enjoy overseeing the fabrication of early prototypes to ensure customer requirements are well understood and met. Carnelian Medical has worked with a highly regarded cohort of international clients on projects that include First in Human clinical trials and Breakthrough Device designation.

 

Carnelian Medical employs the guidance of ISO 13485 in the design, development and manufacture of medical device components and assemblies. We support our clients by providing rigorous Quality System controls in areas including supplier management, documentation control, equipment qualification, production controls, product traceability, and risk management.  Carnelian Medical manages early phase drawings, specifications and work instructions to ensure client design history requirements are supported.