Quality you and your customers can count on

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