Design & Engineering

CFI Medical Solutions collaborates with companies and clinicians to design and engineer medical devices and accessories.  A multi-disciplined staff of designers, electrical and mechanical engineers, and technicians utilize the latest technology for solid modeling, simulations, renderings and direct translation to our state-of-the-art CNC equipment.  FDA QSR compliant and ISO 13485 certified design controls promote the development of concepts and prototypes that efficiently translate to full production.  CFI is well versed with the requirements of international medical device equipment safety standards such as:

Design & Engineering

  • IEC 60601-1 Rev 3 for Mechanical & Electrical Equipment
  • IEC 60601-2-46 for Operating Room Tables
  • IEC 62366 for Medical Devices
  • IEC 14971 for Risk Management

Additionally, CFI is highly experienced with sterile medical device design and development.  Compliance with critical standards such as:

  • ISO 11135 Sterilization of health care products – Ethylene oxide
  • ISO 11607 Packaging for terminally sterilized medical devices
  • ISO 10993 Biological evaluation of medical devices

Contact CFI for assistance with your next design and engineering program.

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