| Contract manufactured medical devices are widely | | | | sterile and non-sterile products. The assembly |
| used in a variety of markets such as critical care, | | | | processes and capabilities of medical device contract |
| emergency room, home health care and industrial | | | | manufacturing range from simple products such as |
| laboratories. The critical care section includes medical | | | | tubing sets to ultra precision electro-mechanical |
| devices for respiratory therapy and operating rooms. | | | | devices. Most contract manufacturers deal with high |
| The emergency room includes the medical devices | | | | volume disposable and low volume reusable device |
| for the cardiac lab, labor and delivery. Medical devices | | | | manufacturing. They also have a full service injection |
| used in home health care such as a doctor?s office | | | | molding program such as injection mold design, |
| and medical laboratories can also be manufactured on | | | | fabrication and clean room injection molding. The cost |
| contract basis. Contract manufactured medical | | | | of machines for the injection molding process is high. |
| products usually include simple tubing sets, very | | | | The design of the right mold is also difficult. Hence |
| complicated bio-sensors, and even ultra-precision | | | | most customers go for contract manufacturers for |
| devices made from plastics, metals, electronics and | | | | the injection molding processes. |
| ceramics. | | | | Some medical device contract manufacturers offer |
| Medical device contract manufacturing companies | | | | ethylene oxide and radiation sterilization coordination. |
| offer clean room and non-clean room assembly, | | | | A wide range of process capabilities, giving more care |
| testing and packaging services for class I, class II and | | | | towards the quality, responsiveness and efficient |
| class III medical devices. Class I medical devices do | | | | operation are the main features of an ideal medical |
| not cause any harm to the user and are very simple | | | | device contract manufacturer. |
| in design, compared to the other two devices. In | | | | Medical device contract manufacturers usually work |
| class II devices there are special controls to ensure | | | | closely with the original equipment manufacturing |
| safety and effectiveness in addition to the general | | | | companies. The contract manufacturing of medical |
| control. Class III devices require pre-market approval | | | | devices includes traditional, high quality contract |
| to ensure device safety and effectiveness. | | | | manufacturing services. It also introduces automation |
| Medical device contract manufacturers also provide | | | | design and building capabilities. |