What Is Medical Device Design?
The development of medical devices often spans multiple engineering domains such as software, mechanical, electrical, and fluidic systems as well as biomedical data analysis. Beyond basic development, the medical device design process also encompasses verification and validation activities that ensure the device meets specifications and complies with international regulations and standards. These standards, such as IEC 62304, certify that the device is safe for medical use. Medical device design practices are applied on a wide range of devices including:
- Therapeutic devices (ventilators, infusion pumps, dialysis machines, and pacemakers)
- Radiology imaging devices (MRI, CT, X-ray, and ultrasound scanners)
- In vitro diagnostic devices, including laboratory and point-of-care testing equipment
- Patient monitoring devices (ECG, EEG, EMG, and MEG)
- Hearing devices, including on-ear hearing aids and cochlear implants
- Surgical devices, including surgical robots and endoscopic cutters
To learn more about medical device design, see MATLAB and Simulink for Medical Devices.