Breakthrough Medical Devices - Verdict Medical Devices
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Breakthrough Medical Devices

As your ISO 13485 certified manufacturer partner of custom springs, design and assembly, Vulcan Spring & Mfg. Co. believes we have a responsibility to our clients and public to notify them of extraordinary opportunities that go beyond the spring.

The FDA has developed The Breakthrough Device Program, an initiative to provide patients and healthcare providers with these essential medical devices and device-led combination products in a timely manner.

This voluntary program requires these devices to be used to “provide for more effective treatment or diagnosis if life-threatening or irreversibly debilitating diseases or conditions.”

Why Vulcan Cares

The springs we manufacture are impactful and go beyond simple usage. Springs are essential for medical devices and healthcare applications, including surgical staplers, drug infusers & delivery systems, MRI & x-ray machines, and table & bed lift mechanisms.

A spring is just one piece to the puzzle. It can seem like a significantly small component compared to the final product. Yet, it plays a crucial role in the functionality of life saving devices and adds to the capabilities of healthcare applications.

For those interested in learning more about The Breakthrough Device Program we encourage you to review the U.S. Food & Drug Administration site and read through their Guidance packet.

For more information about the program, please contact BreakthroughDevicesProgram@fda.hhs.gov.

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