Located in Knoxville, Tennessee, FabriTEQ offers a wide range of manufacturing solutions. Whether you’re looking for disposal healthcare devices, labeling for consumer goods, or affordable packaging for your product, FabriTEQ has the experience and skill to make your dream a reality. Contact us today for a quote.
FabriTEQ’s current Good Manufacturing Practices and our ISO 13485 Certification
When FabriTEQ was founded in February 2014, quality and regulatory compliance were built into the business on Day 1. Our first hire was a Quality Manager who built a quality system that aligned with FDA Medical Device requirements and satisfied the ISO 13485 certification conditions.
Current Good Manufacturing Practices (cGMP) is an FDA regulation for Medical Device Manufacturers. FabriTEQ registered with the FDA May 30, 2014 after completing rigorous internal cGMP training with all our employees. FabriTEQ also implemented the FDA requirements for a compliant quality system for Medical Device manufacturing. After 7 years of FDA registration and millions of devices sold, FabriTEQ has never had an FDA complaint or investigation. In 2017 FabriTEQ was audited by the FDA and found to be compliant to the regulations. FabriTEQ continues to maintain FDA registration and works diligently to ensure compliance to all regulations for Medical Device manufacturers.
ISO 13485:2016 is an international standard with a set of requirements for a quality management system specific to the medical devices industry. In February 2014 FabriTEQ began building a compliant ISO 13485 Quality Management System. Six months later in August 2014 FabriTEQ was awarded ISO 13485 certification. Each year thereafter, FabriTEQ has been audited by Eagle Registration for compliance to the ISO 13485 standard. Every audit has been successful and FabriTEQ has continuously maintained our ISO 13485 certification.