The FabriTEQ Quality Management System complies with FDA Medical Device current Good Manufacturing Practices (cGMP) and is certified to ISO 13485:2016 Medical Device Quality Management System Requirements for Regulatory Purposes.
The FabriTEQ Quality Management System ensures a reliable, consistent, and compliant product produced at an FDA registered facility.
The regulatory framework of the FDA and the strength of ISO 13485:2016 certification give you confidence that FabriTEQ products meet our customer’s specifications and comply with US regulatory requirements.
The FabriTEQ Quality Management System offers our customers:
- Full traceability from sourcing to shipping
- Monitoring and control of production processes to ensure a consistent and quality product
- FDA compliant Device Master Records and Device History Records
- In-process and Final Inspection
- cGMP compliant Production and Printing Departments
- Quality Processes such as Corrective Actions (CAPA), 1st article inspections, Certificates of Conformance or Analysis, Verifications and Validations.
- Quality Services include: Certified Class 8 Production Cleanroom, Sterile Barrier Pouch Systems, Sterilization outsourcing, Product Validation, Risk Assessments and Management, FDA compliant labeling, UDI Barcode verification, and much more.
FabriTEQ’s 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.”