Class III Medical Device Fabrication

Welding and Sealing of Medical Device Components

The Medical Device Welding Specialists

Litron understands that with a Class III Medical Device comes strict regulations and quality standards. With that in mind we offer not only production services, but design and engineering services to complete quality control.

Concept to Completion

Litron’s engineering staff can assist in the optimal design of your medical device. Our extensive experience in materials, weld-joint design, tool design and laser-based manufacturing will ensure a smooth transition from concept to production.

Full Validation Services

We know that in the medical industry validation is key. At Litron we offer statistically validated processes, so you have all the documents required for your Class III medical device.

Prototypes to Production Runs

No matter the quantity, Litron can handle a single prototype run, to several hundreds or thousands of parts. With our commitment to quality you can rest assured that the last part finished will meet the same high standards as the first.

Capable of Handling Most Any Class III Device:

  • Pacemakers
  • Sensing Implants
  • Ventricular Pumps
  • Defibrillators
  • Neural Stimulation
  • Artificial Hearts
  • Cochlear Implants
  • Stimulation Implants
  • Many others
 

Class 10K Cleanroom

Litron is dedicated to providing the highest quality hermetic environment for the welding and sealing of your Class III Medical Devices in an inert environment. To ensure your components are fully protected we’ve built a Class 10K Cleanroom environment equipped with state-of-the-art laser welding and sealing systems and testing centers.

Our Class 10K Cleanroom is ISO 9001:2008 and ANSI/ESD S20.20-2007 Certified. We are committed to ensuring that every part that leaves our facility is precise. With that in mind, we welcome audits by your own team of experts to ensure all of our systems and processes are being conducted to the highest standards.

Contact Litron Inc at 1-866-LITRON-1
 
 

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