Manufacturing Medical Devices

Medical devices are critical to the quality of health care provided by health-care professionals. They facilitate or improve the quality of many treatment procedures. Applications range from simple devices such as splints or casts, to complex, functional implantable devices that support or sustain life. The biomaterials used to construct medical devices and the requirements for assured quality, including lot-to-lot reproducibility, vary widely with device application and the type of material or materials used in device construction. Preproduction planning and testing, acute and chronic biocompatibility testing, and lot-to-lot control of biological characteristics must also be considered. This paper discusses these and other aspects of manufacturing medical devices.