Medical and Life Sciences

Nuvation’s 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).

Our extensive medical device experience includes 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. Industry standards we design for include 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.

Life science companies often bring their innovative concepts to Nuvation Engineering during the research and development phase. We take the time to study and understand each client’s unique technology and application, and help complete any remaining feasibility or proof-of-concept tasks. Clients often include Nuvation Engineering as the co-inventor on patent applications, although there is no obligation to do so.

MEDICAL DEVICE DESIGN EXPERTISE:

Experienced with design to the following standards:
- IEC 60601-1-x
- ISO 62304
- ISO 14971
- FDA Premarket Approval including 510(k) 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