Sanbor Medical Blog

Cable Assemblies, Wiring Harnesses, and PCBA: The Backbone of Medical Device Quality

Written by Sean Campbell | Aug 19, 2025 2:38:26 PM

When we think of medical devices, we often focus on the final product that doctors and patients see. But behind every reliable medical device is a network of critical components: cable assemblies, wiring harnesses, and printed circuit board assemblies (PCBAs). These components ensure that the device operates safely and consistently, meeting stringent FDA requirements.

Understanding the Role of These Components

First off, cable assemblies and wiring harnesses are essentially the nervous system of a medical device. They connect different parts of the device, ensuring that signals and power flow reliably internally and externally.

PCBAs, on the other hand, are the brain, carrying the electronic circuits that allow the device to function. If any of these elements fail or do not meet the required standards, the entire device can be compromised.

 

FDA Regulations and Why They Matter

Now, medical devices are heavily regulated by the FDA to ensure they are safe for patients. That means every component, including these cable assemblies and PCBAs, needs to meet strict standards. The FDA looks at everything from the materials used to the manufacturing processes. And that’s where we come in.

 

Sanbor Medical’s Commitment to Quality and Cost-Efficiency

At Sanbor Medical, we understand how labor-intensive these components can be. That’s why we have FDA-inspected and registered factories not just in the United States, but also in Southeast Asia, including Singapore and Indonesia. This global footprint means we can help medical device OEMs reduce costs by leveraging more cost-effective labor markets while maintaining the high quality required by the FDA.

Our Pennsylvania facility is a key part of our operations. It focuses on more specialized assemblies rather than the labor-intensive cable and wiring harnesses. That allows us to optimize costs and deliver the best of both worlds: U.S.-based quality control and overseas cost efficiency.

By partnering with Sanbor Medical, OEMs can ensure that these critical components meet all regulatory requirements without breaking the bank.

Ready to learn more? Contact our team today