Armorbon is a tooling, production, and design fulfillment company with over 20 years of expertise in quality control, problem-solving, and injection molding. We offer comprehensive design, tooling, and production for all of your medical device production needs. With over two decades of experience, our company has unique insight into material properties and medical device design.

 

Armorbon can supply medical devices for FDA-registered products along with other Class I and Class II medical devices and components. We specialize in Class I and Class II medical device manufacturing, working with medical grade silicone (LSR) and thermoplastic, which capibilites include injection molding and overmolding.

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WHAT IS A MEDICAL DEVICE?

A medical device can be any sort of equipment intended for the care and treatment of patients. A medical device may be something used in medical treatment, prevention, or health maintenance.

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The FDA (Food and Drug Administration) requires the facilities that produce medical equipment to meet certain quality, consistency, and safety standards for the sake of the people who use these products.

 

The FDA recognized three types of medical devices: Class I, II, and III.

• Class I has the lowest risk of injury and is not designed to sustain human life, such as a face mask. These can be with or without exemptions.

• Class II has more oversight. These have to meet certain performance standards, but do not maintain human life either. These can be with or without exemptions.

•  Class III must be approved before reaching the market and have a higher chance of incurring injury with use.

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