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FDA Registered Manufacturer

EmbedTek is registered with the FDA as a Contract Manufacturer, authorized to produce and manufacture medical devices. We currently hold  a certificate of registration to ISO 13485:2016. EmbedTek specializes in optimizing design improvements while streamlining the supply chain.

Read our Case Study to learn more about how we can be your ideal partner to accelerate market launch and your market share.

Surgical Visualization Case Study

Project requirements

  • Compact computer system providing 3D-image processing for robotic-assisted surgery
  • Medically-rated with physical and thermal specifications
  • High-speed, long-distance interconnect between camera and computing system
  • EmbedTek manufactures entire medical devices with drop shipping to the end customer

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In a snapshot

A medical device manufacturer engaged EmbedTek to evaluate the communication inside an image generator for a new line of surgical visualization tools.

We developed a new computer system that incorporated powerful graphics technology and conformed to the physical and design standards of the rest of the device. This included:

  • a new, specialized positioning of the visualization tools ergonomics for the surgeon;
  • and a slim console that left a very small opening for the chassis, and little room for airflow.

Our engineering team worked closely with the customer to design the computer system using commercial-off-the-shelf (COTS) central processing units (CPUs) and video processing components. We created a flow-through chassis that included a large fan with a low acoustic footprint.  And, we worked with the appropriate regulatory agencies to help the customer get the needed approvals for the medical device.

The end result is a cutting edge technology that is quickly gaining acceptance, with a manufacturing and supply chain that has the flexibility and scalability to keep up. Our trusted, long-term partnership means that the customer can drive to the next innovation in the medical device field without having to also be an expert on how to get here.

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