Quality

Strategix for Quality

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  • FDA registered
  • ISO 13485:2016
  • pFMEA
  • Validated Special Processes
  • Control Plans
  • Gage R and R
  • Calibration
  • CE & FDA experience
  • Working Knowledge of GD&T ASME Y14.5 -2009
  • Calibration: IEC/ISO 17025-2005 accredited lab

 

Strategix is committed to delivering the highest quality products for our customers. As a contract manufacturer of medical devices, the quality of our products is guaranteed through the implementation of an ISO-certified Quality Management System that defines customer requirements and uses statistical analysis, process validation, lean manufacturing and high-yield machining to deliver medical devices of superior quality.

Each step of our lean manufacturing process is as important as the medical device being made and the customer being served. Integrating statistical analysis into proven systems, our contract manufacturing team is able to determine solutions to potential problems before they arise.

Strategix monitors the manufacturing process and ensures the quality of its products through the latest technology and engineering experts who are dedicated to process validation and quality control. From contract initiation to product delivery, our attention to detail results in high-yield machining and peerless product quality. Customers can rest assured that our finished products will meet their requirements and are backed by our ISO 13485:2016 certification.

Click here for a copy of our ISO 13485:2016 certificate

To contact our Quality Manager directly with any questions, please email scott.steelman@strategixmedical.com

 
Hexagon Global Performance CMM