Contract Electronics Manufacturing and PCB Assembly Blog

Zentech, a FDA Certified Medical Device and ISO 13485 Facility

Posted by Stephanie Weaver on Tue, Mar 28, 2017 @ 03:51 PM

SMT-soldering.jpgZentech Manufacturing has provided life critical, advanced technology medical devices and high-reliability and high-complexity electronics contract manufacturing to the U.S. medical industry for nineteen years.

Recently recognized as one of the Top Ten Electronics Contract Manufacturing (CM) organizations in the Northeastern United States, Zentech is also one of less than ten CM’s in the United States that has been IPC Validation Services Certified as an IPC-610 Class 3 Trusted Source for medical and military circuit card assembly. Zentech is also a FDA Certified Medical Device Manufacturing Facility and ISO 13485 certified.

In recognition of Zentech’s outstanding performance supporting all printed circuit assembly, unit level integration and testing requirements, Zentech was recently recognized by several of their medical industry clients as their Supplier of the Year. 

As Zentech has supported some medical device programs for more than a decade, the evolution of the customer’s platform during this period has been supported on a sustaining engineering basis by Zentech’s engineering team

Turn-key solutions for your medical device include:

  • Participation in core design activities
  • Review and drive solutions to compliance test failures.
  • Manage entire sustaining engineering process  
  • Implement design changes
  • Test fixture design and development
  • Full Turnkey Production and Test
  • Repair and Refurbishment Depot 

Zentech is a premier electronics contract manufacturer in the medical device industry. Do you manufacture life critical, highly complex medical devices? Contact Zentech today to learn more about our turn-key solutions.

 

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