Quality & Regulatory

Quality & Regulatory

Tegra Medical is focused 100-percent on the medical device industry, so we understand the critical nature of the components and devices we produce. Quality is as important to us as it is to you.

Quality and Regulatory

The cost of sub-standard quality can be significant, so we have implemented robust quality procedures and cGMP practices to ensure adherence to all quality requirements and customer specifications. To ensure the highest levels of quality for your medical device, these are some of the actions we take:

  • Examine first pass yields
  • Use real-time statistical process control (SPC)
  • Deploy lean manufacturing/Six Sigma tools to eliminate waste and remove variation from our manufacturing processes
  • Employ Black Belt-certified engineers who play a key role in driving our quality and continuous improvement focus throughout the organization
  • Validate special processes to ensure repeatability, minimize inspection time and reduce cost
  • Are ISO 13485:2003 certified, compliant with FDA’s Quality System Regulations (QSR) in all facilities, and registered with the FDA as a contract manufacturer
  • Train our employees to ensure that we continuously improve critical skill sets and integrate a quality discipline into everything we do
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The Tegra Medical team has extensive experience with Class II and III devices and uses various tools to aid in risk management:

  • New equipment IQ, OQ, PQ procedures
  • Process Failure Modes Effect Analysis (PFMEA)
  • Design of Experiments (DOE)
  • Control Plans
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