What Does It Take to Get a Medical Device to Market?

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From concept to market for medical devices, learn about regulations, development, launch, and postmarket management for new healthcare tech.

If you are an entrepreneur or innovator in the healthcare industry or are considering entering the space, it’s important to understand what is involved in getting a medical device to market. This is a journey fraught with challenges, complexities, and regulatory scrutiny. For those involved in the design, development, and distribution of medical technologies, this article will offer a high-level roadmap of the process from concept to market.

Medical devices What Are Medical Devices? Medical devices are products or equipment used in healthcare for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. They range from simple items like thermometers to complex technologies such as pacemakers and MRI machines. Unlike pharmaceuticals, medical devices act through physical means, including mechanical action, physical barriers, or replacement of body parts or functions.

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