Quality & Regulatory

Cirtec weaves quality assurance into every step of the manufacturing process by:

  • Offering ISO Class 7 and Class 8 cleanrooms for molding, extruding, secondary and finishing operations
  • Working directly with customer engineers to determine process validation requirements
  • Utilizing and developing automated non-contact vision measurement equipment to perform dimensional analysis and statistical process control in a real-time setting
  • Incorporating a customized, integrated Work Management System to improve communication throughout the production cycle, allowing key stakeholders to continuously monitor progress

Lean/Six Sigma culture:

  • Comprehensive training program for Operators and Inspectors, including a thorough certification program for demonstrated proficiency
  • Comprehensive verification and validation processes from molding to product finishing
  • Six Sigma DMAIC process in place to ensure all critical processes are established and validated to > 1.33 Cpk capability
  • Layered Process Audit (LPA) systems embedded into manufacturing process
  • 100% non-destructive inspection during manufacturing process followed by comprehensive component inspection and DHR review by a dedicated QC team
  • In-house capability for development and fabrication of highly automated finishing and inspection technology, currently capable of inspecting up to 12 parts/second

In-House Material Science:

  • Material development for performance and manufacturability
  • Customer coordinated development of material specifications based on device application
  • Select material testing to ensure specification compliance is completed on site
  • Sophisticated Material and Metrology labs assure the highest quality materials and exact tolerancing for precision components
  • Materials lab testing machines: RPA, MDR, UTM, DSC, TGA, AA tester, DMA, UV-Vis, FTIR, etc.

Certifications and Compliance


STURTEVANT, WI: ISO 13485: 2016

ROCK HILL, SC: FDA Registered and ISO 13485: 2016

Regulatory Affairs


Declarations for material compliance generated upon customer request, including:

  • RoHS
  • Phthalates
  • Conflict minerals
  • CA Prop 65
  • Animal derived constituents etc.

Sustainability & Environmental Management

Cirtec aspires to minimize its impact on the environment and maximize the effective use of resources.

The Cirtec Centers of Excellence (Rock Hill, SC; Sturtevant, WI) are sites dedicated to environmental management and sustainability. As part of their effort to reduce environmental impact, these facilities have put programs into place that track, monitor and improve environmental goals typified by reducing landfill waste generation and overall energy consumption.