Quality you and your customers can count on

Our Quality Policy

FabriTEQ is committed to providing a product which complies with all regulatory and customer requirements and to maintaining the effectiveness of the quality management system.

FabriTEQ Quality Management System means consistent product performance

FabriTEQ’s Quality Management System ensures that your product consistently meets all your specifications and quality requirements. You are assured of reliable, consistent, compliant products from an FDA-registered facility; your customers are assured of quality they can trust.

  • Full traceability, from sourcing to shipping
  • Monitoring and control of production processes for consistency and quality requirements
  • FDA-compliant Device Master Records and Device History Records
  • cGMP-compliant Production and Printing departments
  • Inspection and Test: first articles, burst testing, UDI barcode verification, final release testing, and product certification
  • Formal, documented quality processes such as Corrective Actions (CAPA), Certificates of Conformance or Analysis, Verifications and Validations
  • Production in an ISO Class 8 certified clean room
  • Sterile barrier pouch systems
  • Sterilization outsourcing
  • Product validation
  • FDA-compliant labeling

Our Commitment to Quality

Our quality culture and processes provide our customers confidence that their products meet their requirements and are manufactured in a compliant environment.
Compliance and Certifications

  • Compliant to FDA current Good Manufacturing Practices (cGMP)
  • Certified to ISO 13485:2016: Medical devices — Quality management systems — Requirements for regulatory purposes
  • Certified ISO Class 8 Manufacturing Clean Room
  • FDA registered as a Contract Manufacturer and a Packager/Re-labeler in several medical device categories

Our Certifications give you peace of mind

FabriTEQ maintains these certifications and registrations to assure the highest quality for your products:

  • ISO 13485:2016 Medical Device certification
  • FDA current Good Manufacturing Practices (cGMP) compliant
  • ISO Class 8 Certified Clean Room
  • FDA registered as a:
    • Contract Manufacturer
    • Packager/Re-labeler

Find out how our dedicated quality management system can make a difference for your project
Call 865-622-4540 or email sales@fabriTEQ.com now!