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The Importance of the FDA Registration of Medical Device Manufacturers

Only after finishing medical school, completing a residency, and acquiring the necessary medical license can a doctor take the Hippocratic Oath, which is one of the most binding documents in history. Hippocrates, of course, is regarded as one of the most revered figures in the field of medicine. By taking the oath, a healthcare professional vows to protect patients from harm, among other things.

While a doctor may have the right education, training, and attitude, these things don’t guarantee that he can always keep patients protected from harm. Risks to patients’ lives can be great when it comes to complex procedures like bone grafting or cardiac surgeries, particularly if the doctor unwittingly uses a low-quality bone or cardiac implant that causes complications and puts the patient’s life in danger. To avoid such a scenario, healthcare practitioners must choose only reputable medical device manufacturers as suppliers.

Increasing demand for medical products is driving growth in the medical device manufacturing industry, so it’s not unlikely for a few less than qualified companies to jump on the bandwagon. Yet to succeed in this particular industry, one must have a strong background in the biological sciences as well as in engineering. In-depth knowledge in these disciplines is necessary for the design and manufacture of quality medical devices.

A Food and Drug Administration (FDA) registration is also critical when choosing medical device companies. The FDA regulates standards for medical devices that are manufactured and sold in the United States. Apart from FDA registration, reputable manufacturers like Phoenix DeVentures typically possess industry certification such as ISO 13485 and a medical manufacturing license from the state.

Similar to medications, the FDA requires that medical device manufacturers must first establish that their products are indeed safe for use before they can be distributed or sold. The FDA also requires medical device makers to demonstrate adherence to proper manufacturing processes and practices. Direct metal sintering, in particular, involves the use of 3D computer-aided design (CAD) modeling that allows parts of medical devices to be created layer by layer (of about 20 micrometre thick) in a few hours without need for tooling.

Medical device parts share certain similarities with auto parts in terms of manufacturing techniques. Like auto parts, medical devices must be made according to the standards set by an industry-wide regulating body.