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Thermal Circuits as a Global Supplier to FDA-Approved Medical Device Manufacturers


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During 2007, Thermal Circuits’ President and CEO challenged Thermal’s Business Development Team to continue revenue and income growth. At that time, it was decided to focus much of the firm’s marketing and development budgets on re-positioning Thermal Circuits as a Global Supplier to FDA-Approved Medical Device Manufacturers.

Immediately following that decision, an objective was rolled out to Thermal’s Management Team to develop an enterprise-wide enhancement to its Quality Management System. Specifically, ISO13485:2003 would be maintained and our Quality Management System would be added/obtained in an expeditious fashion.

Hard examples of the prerequisite improvements implemented by Thermal include:

  • Identify and communicate all key and critical to quality requirements.
  • Attain and continuously improve consistent and valid results that demonstrate the highest possible quality from processes and procedures that represent all aspects of the business.
  • Provide training for engineering and quality personnel in IQ, OQ, and PQ.
  • Develop control plans, process validation reports, and risk assessments (PFMEA).
  • Require acceptable process capability studies on sourced materials.
  • Enhance design drawings, route sheets, supplement sheets, and workmanship standards to better control the quality or raw material, work in process, finished goods, and packaging.

The results of these and many additional actions have been:

  • Thermal maintains ISO13485:2003 registration.
  • Thermal received quality management system registration.
  • Thermal has increased its revenue beyond its pre-recession benchmark.
  • Thermal has increased its sales to the medical market niche from < 10 % to > 40 % of total revenue.
  • Thermal has replaced competitors by providing superior quality, delivery, value, and service.
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