Medical devices include everything from simple diagnostic tests such as blood glucose meters and pregnancy test kits to sophisticated surgical robots and implantable pacemakers. Therefore, ensuring a functional design for medical devices need to be done the best way possible.

Classification of medical devices falls under Class I, Class II, or Class 3. This classification differentiates between low-risk, medium-risk, high-risk devices. For example, Class I is a low-risk device like handheld surgical dev. Class II is an intermediate-risk device like a Computed Tomography (CT) scanner.

Engineering and manufacturing devices that integrate different technologies is crucial for innovating in the medical device industry. Integrating lighting, optical, and laser systems and complex accessories nowadays are also essential, not only to have them integrated but that they are fully functional. Are you able to trust just anybody doing the right job without taking much of your budget and time?

Manufacturing capabilities that match your project’s needs


At ARRK North America Inc. we approach medical device design using a structured process that starts by defining the scope of work. In some cases, it is possible to determine the project upfront. For others, the client needs to know what they want before they start working on the project. Once the scope is defined, we determine the appropriate level of detail to go into each aspect of the project.

The purpose of a medical device is to improve human health through the application of science and technology. The term “medical device” encompasses a wide range of products used by patients or healthcare providers to diagnose, prevent, treat, monitor, or relieve the disease, injury, pain, or other physical conditions.

Depending on the class of the medical device you need to design, prototype, develop or manufacture, having a team in which they can consider everything can be found with ARRK North America Inc. Our team has experience creating entire medical devices to a single large device component.

These are the two main reasons our designs and manufacturing of medical devices can provide the best results:

  • Ensuring functionality is within our capabilities: Providing a medical device with mechanical aspects with different requirements, either strength or flexibility, even we can give a mixture of both to withstand its intended usage with success, especially if it’s a repeated-use device.
  • Engineering the electrical system: It can encompass powering mechanical movements, having sensors to acquire external information, or monitoring the machine itself.
  • Keeping your original design: When moving into manufacturing the devices, most companies respond that the original design needs to change, here at ARRK we make the difference by finding ways of making the product just as you imagined it.

Solutions for the best outcome for your medical device design manufacturing process

Consistency and reliability are part of our mission to make your idea a reality. ARRK North America Inc. creates accurate and high-quality cast copies with an immaculate finish from start to finish of a project. Our Low Volume Production solutions can provide your medical device with the look and best functional outcome for its intended usage. Contact us at (844) 661-1993 or fill out our form to Get a Quote.

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