A Guide to Contract Manufacturing of Medical Devices
There are a wide variety of markets that use contract manufactured medical devices. These markets include emergency rooms, home health care, critical care, and industrial laboratories. The emergency room market includes medical devices for the cardiac lab, labor and delivery. Medical devices used for the doctor’s office that are used in home health care are also contract manufactured together with medical devices used in medical or industrial laboratories. The operating rooms and respiratory therapy are part of the critical care facilities that have medical devices that are contract manufactured. Simple tubing sets, very complicated bio-sensors, and ultra-precision devices that are made from plastics, metals, ceramics, and electronics, are also medical devices that are contract manufactured.
You can also order products like clean room and non-clean room assemblies, and testing and packaging services for class I, class II and class III medical devices, from your medical device contract manufacturer. Class I medical devices are simple devices that have no risk of harm to the user. These devices have simple designs compared to class II, and class III devices. Class II devices are those with general control but also includes special controls that are for its safety and effectiveness. To ensure device safety and effectiveness, the class III devices require pre-market approval.
Medical device contract manufacturers can also provide both sterile and non-sterile products. From simple devices to very complicated ones, contract manufacturing companies have processes and capabilities to assemble them and some of these basic and complex devices include simple tubing sets to complicated equipment like ultra-precision electro-mechanical devices. High volume disposable devices and low volume reusable devices can also be contract marketed. Full service injection molding programs such as injection mold design, fabrication, and clean room injection molding are also offered by contract manufacturing companies. Contract manufacturers uses expensive machines for the injection molding process. Coming up with the right mold design is also very complicated. This is why most customers go for contract manufacturers for the injection molding processes.
You can also find contract manufacturing companies that offer ethylene oxide and radiation sterilization coordination. An ideal medical device contract manufacturer will have a wide range of process capabilities that give more care towards the quality, responsiveness, and efficient operation.
Medical device contract manufacturers work closely with the original equipment manufacturing companies. Contract manufacturing of medical devices include traditional, high quality contract manufacturing services. These companies also offer automation design and they also have building capabiltiies.
If you are a medical facility, then you can search for contract marketing companies offering their services online.