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Nuvation has medical device design experience across a wide range of technologies, including: ultrasound, intravascular motor drive units, blood glucose monitoring, kidney dialysis, transcranial magnetic stimulation, endoscopy, respiratory therapy, and invasive robotic surgical equipment. We often co-develop medical devices with our trusted mechanical engineering partners and ISO 13485 certified EMS firms.

Nuvation can provide engineering support for all phases of the medical device development process. Our medical device design engineers can take your design from a napkin sketch to a functioning prototype, and then test and refine that prototype to be ready for clinical trials, validation and verification (V&V). We have experience with the most important industry standards for medical device design: IEC 60601-1-x (Medical Electrical Equipment Safety), ISO 62304 (Software Life Cycle Processes for Medical Devices), ISO 14971 (Risk Management for Medical Devices), and others. Our software design methodology is compatible with the process requirements outlined in ISO 62304, and we can provide a technical documentation package thorough enough to meet the stringent requirements of CE mark agencies and other notified bodies. Throughout the process Nuvation will work closely with your team to ensure we develop a medical device that is safe, effective, reliable, and meets the needs of your patients.

Medical Device Design Expertise:

  • Experienced with design to the following standards:
    • IEC 60601-1-x
    • ISO 62304
    • ISO 14971
    • FDA Premarket Approval including 510K and Level 3 development
  • Ultrasound applications (both for imaging, and therapeutic purposes)
  • Mechanical Ventilator design (for assisted breathing)
  • Kidney dialysis machines
  • Blood glucose meters
  • Robotic endoscopy
  • Lithotripsy devices (i.e. for kidney stone ablation)
  • Transcranial Magnetic Stimulation (for migraine headache treatment)
  • Remote patient monitors
  • Vision and dental-care devices
  • Life-critical electronics used in ventilators, dialysis, and brain surgery