Quality System

 

QUALITY MANAGEMENT SYSTEM

The ATEX Quality Management System is certified to the ISO 13485:2003 standard.  All of our design, production, and assembly processes strictly adhere to the ISO 13485:2003 standard (ATEX ISO13485:2003 Certificate). We build in standard operating procedures and programs resulting in implantable fabrics that conform to your specifications.

Computerized Monitoring Processes

ATEX’s proprietary software integrates all of our manufacturing systems to ensure overall product quality, consistency and traceability.

ATEX’s extensive automated systems monitor, manage and control manufacturing processes, inventory management and product delivery.

Cleanliness Standards

Our manufacturing areas are contained within a controlled environment. Our personnel wear protective clothing to keep the work environment free from contamination. Our machines and equipment are routinely maintained to meet the highest standards of cleanliness – assuring you of adherence to your cleanliness requirements.

Development Programs

Partnering with our customers is the best way to ensure continued mutual success. This successful partnership is directly linked to strict conformance to our customer’s design and delivery requirements.

ATEX development team members offer project management assistance and participate in customer development teams.  Participation in Customer Development Teams assures that we produce medical textile components that help to optimize your medical device performance.

We integrate our clinical expertise, textile design expertise, and manufacturing expertise into the development process resulting in an optimal component/device performance relationship.

Document Control and Management

We understand that customer’s requirements change – changes that often directly affect the construction of the implantable medical textiles that we produce.  ATEX’s document control management system assures you that your component is produced using the latest customer specifications and is produced only by manufacturing associates that have been properly trained to the latest specification.

 

 

ISO 13485

Certificate

For a copy of ATEX Technologies' ISO 13485:2003 certificate, click the button below.

ISO 13485 Certificate