Medical device manufacturing produces equipment for medical diagnosis and treatment, tightly regulated due to the potential harm of device failure. Products must be approved by regulatory agencies before sale, and can include a wide range of equipment. Companies may sell directly to hospitals or through medical equipment suppliers, and trade associations work to promote safety and provide benefits to members.
Medical device manufacturing in a branch of the manufacturing industry dedicated to producing devices used in medical diagnosis and treatment, from surgical tables used in operating theaters to continuous positive airway pressure (CPAP) machines used by apnea patients to manage their condition. Because the failure of a medical device can have serious consequences for a patient or healthcare professional, the manufacturing of medical devices is tightly regulated in many regions of the world. A number of companies specialize in medical device manufacturing or medical device manufacturing as part of their overall services.
Medical devices can include a wide variety of medical equipment, such as heart monitors, MRI machines, implants, fetal heart monitors, anesthesia machines, thermometers, stethoscopes, and surgical instruments. Some countries also classify organisms used in medical diagnosis and treatment, such as bacteriophages, as “medical devices”. Pharmaceuticals, on the other hand, are treated and regulated separately.
A medical device manufacturing company may develop and manufacture a range of products for medical use. However, products must be approved by regulatory agencies before they can be sold. Regulatory agencies inspect products to confirm they are safe, to determine how they can be used, and to see whether or not they adhere to safety standards. Medical imaging devices that use radiation, for example, must be designed with adequate shielding and safeguards to protect patients and technicians from radiation.
Some companies sell directly to hospitals, clinics and health care providers. Because medical devices can be dangerous in the wrong hands, their sale can be limited to authorized personnel or patients who have prescriptions for specific devices. This is designed to ensure that only people who know how to safely protect us and maintain medical devices have access to them. Other manufacturers sell to companies that supply medical equipment. Many companies can make customized products upon request, as long as these products meet safety standards.
As in other areas of the manufacturing sector, medical device manufacturing is represented by a number of trade associations. These groups work with government and regulatory agencies to promote safety and ensure that the cost of doing business does not become onerous. These groups may also represent their members in lawsuits and provide networking opportunities for member companies. Members of such commercial organizations have access to special publications, annual conferences, legal advice and other benefits that can be useful to companies working in the manufacturing of medical devices.
Protect your devices with Threat Protection by NordVPN
