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Medical Device Classification and the Fabrication Role of Precision Metal Stamping in Minneapolis, MN

December 7th, 2017 · No Comments

With over 50 years of experience in quality design, stamping, and assembly capabilities, Thomas Engineering Company offers precision that even the most advanced medical equipment can utilize effectively. Medical equipment and devices are highly regulated in the U.S., and for good reason. Without strict guidelines for medical devices there could be serious consequences when that equipment is put to use. The components TEC manufactures with precision metal stamping for medical devices in Minneapolis, MN, meet FDA standards and quality expectations.

TEC’s role in the production of high quality, FDA-approved medical devices includes precision stamping of micro-miniature, miniature, medium, and ultra-thin components. Our capabilities in thin stamping, stamping intricate parts, handling close tolerances, and thin slotting comprehensively fill the demands of even the most complex, delicate medical device components.

The categorization of medical devices places different types of equipment into three general classes.

Classes of Devices

  1. Class I medical devices include general tools and equipment with direct importance to life sustainment or prevention of life impairment. For example, hospital bed monitors, hearing aids, and electronic vital diagnostics are considered Class I medical devices. TEC precision stamping offers electronic components and other advanced parts for Class I medical devices.
  2. Class II medical devices must meet stricter requirements for FDA approval than Class I devices. The health and safety of patients rely on the accuracy and effectiveness of Class II devices, and because this equipment assists in medical services for more severe health complications and injuries, it must be reliable. With TEC’s advanced part analysis and rapid prototyping, components for Class II medical products are predictively manufactured for a high quality final product.
  3. Class III medical devices are the highest risk equipment, meaning these machines address the most severe and emergency health conditions. This classification also includes a range of devices meeting guidelines for FDA Premarket Approval. Because of the range in complexity of Class III devices, the expertise of TEC engineers and team members in precision stamping services and assembly is key in comprehensive Class III device manufacturing.

TEC supplies high-quality precision-stamped components for medical equipment in all device classes. From general treatment to emergency equipment, we serve the medical industry with reliability and efficiency to keep device and equipment at industry standards, with continued FDA approval.

To learn more about how we serve the medical industry or for information about the other industries we serve with our precision metal stamping in Minneapolis, MN, contact Thomas Engineering Company at (763) 533-1501 today.

Tags: Metal Stamping · Precision Metal Stamping Services ·


 

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