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Why Is Medical Certification So Important?

Ever wonder just how rigorously medical devices are tested before they end up in your doctor’s office or hospital?

As it turns out, even your infotainment center goes through a series of tests and certifications designed to ensure you experience the safest, most effective medical technology possible. These medical certifications are put in place to enhance patient safety, hile making it possible for hospitals and medical centers to provide the best care.

In order for a device to be used within a hospital or medical setting, it must meet or exceed standards and regulations regarding safety, effectiveness, system integration, and patient experience. Each medical certification is signified with a specific code, which allows medical professionals and government officials to quickly ascertain how a medical device functions and what requirements it has met.

Onyx Healthcare – the leading solution for medically focused computer design manufacturing – is rigorously tested and certified by major government entities, including the Food & Drug Administration (FDA) and the International Standards Organization (ISO). These certifications ensure that our medical devices are continuously providing the best quality care while streamlining functionality in any hospital or clinic.

A small selection of our many certifications include the following:

  • The UL 60601-1 edition 3.1, which sets out requirements for a medical device to achieve certain safety standards.
  • FCC Class A and Class B, which signifies the differences between a medical device that’s for use in a hospital setting versus a device that’s used in a residential setting.
  • FDA Medical Device Class II, which is a label that is applied to a medical device that has a complicated design. In order to earn the Class II certification, a medical device needs to meet certain performance standards and pose minimal risk to an organization.

Medical devices continually need to be recertified in order to demonstrate that they can continue to be safe and effective in a hospital setting.

To learn more about Onyx Healthcare or to view their product catalog, visit http://www.onyxhealthcareusa.com.

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