All About Medical Device Contract Manufacturing

Kimberly Owings
3 min readAug 21, 2018

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For many medical facilities, contract manufacturing of the medical devices that they need is a lot more beneficial than purchasing finished products from original manufacturers. 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. The contract manufactured medical devices used for home health care include those devices that are found in a doctor’s office, and contract manufactured medical devices are also used in medical and industrial laboratories. The operating rooms and respiratory therapy are part of the critical care facilities that have medical devices that are contract manufactured. The contract manufactured medical devices include products such as simple tubing sets, very complicated bio-sensors, and ultra-precision devices that are made from materials including plastics, metals, ceramics, and electronics.

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. In class I medical devices, the products do not cause any harm to the user. These devices have simple designs compared to class II, and class III devices. The class II medical devices are those that have special controls that will ensure its safety and effectiveness in addition to the general control. Devices that need pre-market approval are class III devices and this is required to ensure that the device is safe and effective.

Sterile and non-sterile products are also provided by medical device contract manufacturers. From simple devices to very complicated ones, Mexico contract manufacturing 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. These companies also deal with high volume disposable and low volume reusable device manufacturing. Contract manufacturing companies also offer full service injection molding programs which include injection mold design, fabrication, and clean room injection molding. Contract manufacturers uses expensive machines for the injection molding process. It is also difficult to come up with the right mold design. 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 like contract manufacturing Mexico. If you are looking for the best medical device contract manufacturer, look for one that offers a wide range of process capabilities that focuses on the quality, responsiveness, and efficient operation.

When contract manufacturers process their medical devices, they usually work together with the original equipment manufacturing company. Traditional, high quality contract manufacturing services are the services offered by the best contract manufacturers of medical devices. 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.

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